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Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency (HEART-FID)

Primary Purpose

Heart Failure, Iron-deficiency

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ferric Carboxymaltose
Placebo
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult (≥18 years of age) able to provide signed, written informed consent.
  2. Stable heart failure (NYHA II-IV) on maximally-tolerated background therapy (as determined by the site Principle Investigator) for at least 2 weeks prior to randomization.
  3. Able and willing to perform a 6MWT at the time of randomization.
  4. Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical intervention including coronary artery bypass graft (CABG), valvular repair/replacement, or cardiac resynchronization therapy (CRT) device implantation.

    a. Left ventricular ejection fraction ≤ 40% obtained during the screening visit OR either of the following i. Historical value of ejection fraction ≤ 40% within 24 months of screening visit ii. Historical value of ejection fraction ≤ 30% within 36 months of screening visit

  5. Hemoglobin >9.0 g/dL and < 13.5 g/dL (females) or <15.0 g/dL (males) within 28 days of randomization.
  6. Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%.Patients with screening ferritin <15 ng/mL must have documentation of an appropriate evaluation, as determined by the Principle Investigator, within 3 months of screening and prior to randomization.
  7. Either documented hospitalization for heart failure within 12 months of enrollment or elavated N-terminal-pro-brain natriuretic peptide (NT-proBNP) within 90 days of randomization. a. For patients in normal sinus rhythm: N-terminal-pro-brain natriuretic peptide (NT- proBNP) > 600 pg/mL (or BNP >200 pg/mL) . b . For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP >400 pg/mL) .

Exclusion Criteria:

  1. Known hypersensitivity reaction to any component of FCM.
  2. History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion.
  3. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment.
  4. Uncorrected severe aortic stenosis, severe valvular regurgitation (except mitral regurgitation due to left ventricular dilatation without planned intervention), or left ventricular outflow obstruction requiring intervention.
  5. Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest).
  6. Current or planned mechanical circulatory support or heart transplantation.
  7. Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
  8. Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range).
  9. Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
  10. Active gastrointestinal bleeding.
  11. Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
  12. Inability to return for follow up visits within the necessary windows
  13. Concurrently in a study with investigational product.
  14. No participants with Current COVID-19 Infection into the study.

Sites / Locations

  • Advanced Cardiovascular LLC
  • Advanced Cardiovascular, LLC
  • IMC/Diagnostic & Medical Clinic
  • University of South Alabama
  • Alaska Heart & Vascular Institute
  • Verde Valley Medical Center
  • Clinical Research Institute of Arizona, LLC
  • Carondelet Heart and Vascular Institute - Cardiology East
  • Sparks Regional Medical Center
  • NEA Baptist Clinic
  • Arkansas Heart Hospital
  • Westside Medical Associates of Los Angeles
  • Harbor-UCLA Medical Center
  • Valley Clinical Trials, Inc.
  • TriWest Research Associates, LLC
  • California Heart Specialists
  • First Valley Medical Group
  • Healthcare Partners Affiliation Medical Group
  • Axis Clinical Trials
  • St. Joseph Heritage-Healthcare
  • Radin Cardiovascular Medical Group, Inc.
  • Valley Clinical Trials, Inc.
  • Pasadena Clinical Research
  • Eugene Soroka, MD Inc.
  • VA San Diego Health Care System
  • Interventional Cardiology Medical Group
  • South Denver Cardiology Associates, PC
  • Danbury Hospital
  • Stamford Hospital
  • Christiana Care
  • Alfieri Cardiology
  • Cardiology Associates of South Florida
  • Cardiovascular & Vein Center of Florida
  • Innovative Research of West Florida, Inc.
  • Avail Clinical Research, LLC
  • Riverside Clinical Research
  • Memorial Regional Hospital
  • St. Vincent's Healthcare - Riverside
  • UF Health Jacksonville
  • St. Vincent's Healthcare - Southside Recruiting
  • Mayo Clinic Florida
  • Empire Clinical Research, LLC
  • ProLive Medical Research
  • Cordova Research Institute, LLC
  • Med-Care Research
  • ITB Research
  • Vista Health Research
  • Florida Hospital Transplant Institute
  • Cardiology Partners Clinical Research Institute
  • Springfield Medical Center
  • Broward Research Center
  • South Florida Research Solutions, LLC
  • Cardiology Consultants
  • Avanza Medical Research Center
  • Professional Health Care of Pinellas
  • Indian River Medical Center
  • Cardiology Partners Clinical Research Institute
  • Piedmont Heart Institute - Athens
  • Piedmont Heart Institute
  • University Cardiology Associates, LLC
  • Augusta University
  • Piedmont Heart Institute Fayetteville
  • Georgia Arrhythmia Consultants and Research Institute
  • Mercer University
  • Atlanta Vanguard Research Institute
  • Saint Luke's Boise Medical Center
  • Mount Sinai Hospital Medical Center - Department of Cardiology
  • Medicoricium, LLC
  • Parkview Research Center
  • Franciscan Physician Network - Indiana Heart Physicians
  • St. Vincent Medical Group
  • Indiana University Health Ball Memorial Hospital, Inc.
  • Reid Physician Associates / Reid Health
  • Beacon Medical Group Advanced Cardiovascular Specialists
  • Alexandria Cardiology Clinic
  • Heart Clinic of Hammond
  • Cardiovascular Institute of the South
  • Tulane Heart & Vascular Institute
  • Ochsner Health System
  • Louisiana Heart Center
  • Maine Medical Partners Maine Health Cardiology
  • Anne Arundel Health System Research Institute
  • Sinai Hospital of Baltimore
  • Suburban Hospital
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • NECCR Prima Care Research, LLC
  • Genesys Regional Medical Center
  • Western Michigan University Homer Stryker M.D. School of Medicine
  • Michigan CardioVascular Institute at Covenant Medical Center
  • Allina Health System, dba Abbott Northwestern Hospital
  • Mayo Clinic
  • Cardiology Associates Research, LLC
  • North Kansas City Hospital
  • St. Louis Heart & Vascular, PC
  • Nebraska Heart Institute
  • CHI Health Research Center
  • University Medical Center of Southern Nevada
  • Red Rock Clinical Research, LLC
  • Monmouth Cardiology Associates, LLC
  • Englewood Health
  • Advanced Heart & Vascular Institute of Hunterdon
  • Hackensack University Medical Center
  • Saint Peter's University Hospital
  • Saint Michael's Medical Center
  • Rutgers New Jersey Medical School
  • AtlantiCare Regional Medical Center
  • The Valley Hospital
  • Cardio Metabolic Institute
  • Holy Name Medical Center
  • New York Presbyterian Brooklyn Methodist Hospital
  • Trinity Medical WNY, PC
  • Mount Sinai Hospital
  • Rochester General Hospital
  • Richmond University Medical Center
  • Stony Brook University Hospital
  • Circuit Clinical
  • Northtowns Cardiology, PLLC
  • Asheville Cardiology Associates
  • Duke University Heart Failure Research
  • Medication Management, LLC
  • Wake Forest University Health Sciences
  • Duke Cardiology of Lumberton
  • Monroe Biomedical Research
  • Crossroads Clinical Research, Inc.
  • Pinehurst Medical Clinic, Inc.
  • NC Heart & Vascular Research
  • WakeMed Health and Hospitals
  • PMG Research of Wilmington
  • Trinity Health Center - Medical Arts
  • Aultman Cardiology Clinical Trials
  • The MetroHealth System
  • The Cleveland Clinic Foundation
  • The Ohio State University
  • North Ohio Heart Center
  • North Ohio Heart Center
  • Heart House Research Foundation
  • South Oklahoma Heart Research, LLC
  • Abington Memorial Hospital
  • Penn State Health Holy Spirit Medical Center Geisinger - Cardiology
  • Lancaster General Hospital
  • Drexel University
  • Hospital of the University of Pennsylvania
  • University of Pennsylvania - Perelman Center for Advanced Medicine
  • V.A. Pittsburgh Healthcare System
  • Prisma Health
  • Self Regional Hospital Research Center
  • Carolina Heart Specialists
  • Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc.
  • Stern Cardiovascular Foundation
  • Tennova Healthcare-Turkey Creek Medical Center
  • Parkway Cardiology Associates, PC
  • Amarillo Hearth Clinical Research Institute, Inc.
  • PharmaTex Research
  • Dallas VA Medical Center
  • Cardiovascular Research Institute of Dallas
  • Southwest Family Medicine Associates
  • Baylor University Medical Center
  • Texas Health Research & Education Institute
  • Texas Heart Institute
  • Houston Heart & Vascular Associates
  • Caprock Cardiac Center Research Institute, Inc.
  • Angelina Medical Research, LLC
  • North Dallas Research Associates
  • North Texas Research Associates
  • South Texas Cardiovascular Consultants, PLLC
  • Baylor Scott & White Medical Center
  • PharmaTex Research
  • The University of Texas Health Center at Tyler
  • Wichita Falls Heart Clinic
  • Advanced Clinical Research/Intermountain Heart Center PC
  • The University of Vermont Medical Center
  • Stroobants Cardiovascular Center
  • Riverside Cardiology Specialists
  • Sentara Norfolk General Hospital
  • Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J)
  • VCU Medical Center
  • Carilion Medical Center
  • Selma Medical Associates
  • Providence Regional Medical Center Everett
  • Swedish Heart & Vascular-Advanced Cardiac Support Program
  • Providence Sacred Heart Medical Center & Children's Hospital
  • CHI Franciscan Research Center
  • Walla Walla Clinic
  • Wenatchee Valley Hospital & Clinics
  • Marshfield Clinic
  • Medical College of Wisconsin
  • ProHealth Care Inc / Waukesha Memorial Hospital
  • SWSLHD-Liverpool Hospital
  • Sunshine Coast University Hospital
  • Cairns Hospital
  • The Prince Charles Hospital
  • Core Research Group
  • Gold Coast University Hospital
  • The Queen Elizabeth Hospital
  • SA Heart
  • Flinders Medical Centre
  • Lyell McEwin Hospital
  • Heart Lung Clinic
  • Royal Hobart Hospital
  • Royal Adelaide Hospital
  • Macquarie University - Clinical Trials Unit
  • John Hunter Hospital
  • Epworth HealthCare Clinical Trials
  • MHAT Puls
  • Multiprofile Hospital for Active Treatment: Department of cardiology
  • MHAT Haskovo AD
  • Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology
  • Medical Center Medconsult Pleven OOD
  • МC Hipokrena
  • Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology
  • Second Medical Center-Sofia, EEOD - Department of Cardiology
  • Second Multiprofile Hospital for Active Treatment
  • 5th City Hospital
  • National Multiprofile Transport Hospital Cardiology Clinic
  • Medical Center Hera EOOD - Office of Cardiology
  • Multiprofile Regional Hospital for Active Treatment
  • Medical Center Velingrad 2017" EOOD, Office of Cardiology
  • University of Calbary
  • University of Alberta Hospital
  • South Edmonton Cardiology Consultants
  • Royal Alexandria Hospital
  • Fraser Clinical Trials
  • SMH Cardiology Clinical Trials
  • St. Paul's Hospital
  • Victoria Heart Institute Foundation
  • G.A. Research Associates, Ltd.
  • Health Sciences Centre
  • Nova Scotia Health Authority
  • Manna Research Inc., Burlington South
  • Cambridge Cardiac Care Center
  • Vizel Cardiac Research
  • London Health Sciences Center (LHSC)
  • St. Michael's Hospital
  • Sinai Health System - Mount Sinai Hospital
  • Clinique de Cardiologie de Lévis
  • Montreal Heart Institute
  • McGill University Health Centre (MUHC)
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
  • CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges
  • Recherche Medical St-Jerome Inc.
  • Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec
  • Royal University Hospital
  • Interni kardiologicka klinika FN Brno
  • Kardiologicka ambulance
  • Centrum preventivní kardiologie, Karlovo nám. 32,
  • Centrum preventivní kardiologie
  • General University Hospital in Prague
  • General University Hospital
  • IKEM-Klinika kardiologie
  • JSC Evex Hospitals,Georgia
  • Clinic-LJ
  • Aleksandre Aladashvili Clinic LLC
  • Ltd Israel-Georgian Medical Research Clinic "Helsicore"
  • Ltd Pineo Medical Ecosistem
  • Acad. G. Chapidze Emergency Cardiology Center
  • Bokhua Memorial Cardiovascular Center
  • Tbilisi Heart and Vascular Clinic
  • Ltd TIM- Tbilisi Institute of Medicine
  • Georgian-Dutch Hospital
  • Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai
  • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
  • Debreceni Egyetem Klinikai Központ Kardiológiai Osztály
  • Clinexpert Gyöngyös Kft
  • Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház
  • Bács-Kiskun Megyei Kórház Kardiológiai Osztály
  • Andrea Hornyik, MD
  • Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika,
  • Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály
  • Belvárosi Egészségház Kft
  • Daugavpils Regional Hospital
  • Liepajas Regional Hospital
  • Pauls Stradins Clinical University Hospital
  • Riga East University hospital clinic Gailezers
  • The Hospital of Lithuanian
  • Klaipeda Seaman's Hospital
  • Vilnius University Hospital Santaros Klinikos
  • Wellington Hospital
  • Totara Clinical Research, Health New Lynn
  • North Shore Hospital
  • Auckland City Hospital
  • Middlemore Hospital
  • Christchurch Heart Institute
  • Dunedin Hospital
  • Hauora Tairāwhiti Department of Cardiology
  • Hawke's Bay Hospital
  • Hutt Hospital
  • Nelson Hospital
  • Taranaki Base Hospital
  • Rotorua Hospital
  • Clinical Horizons NEW ZEALAND LTD
  • Oddział Kardiologii WSzS nr 4
  • Biokinetica S.A. Przychodnia Józefów
  • Centrum Medyczne Linden
  • 1 Wojskowy Szpital Klininiczny w Lublinie
  • Ko-Med Centra Kliniczne
  • Szpital Swietej Anny w Miechowie
  • Szpital Świętej Anny w Miechowie
  • Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna
  • Zespol Opieki Zdrowotnej
  • Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej
  • Uniwersyteckie Centrum Kliniczne
  • Centrum Medyczne K2J2
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • 4th Military Hospital
  • Proximum Centrum Usług Medycznych NZOZ
  • Marcin Ogórek, MD, PhD
  • Municipal Autonomous Healthcare Institution "City Clinical Hospital #6
  • Municipal Autonomous Healthcare Institution
  • Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
  • State Budgetary Healthcare Institution of Moscow city "Moscow
  • Private Medical Institution "Euromedservice
  • State Budgetary Institution of Ryazan Region
  • JSC Polyclinic Complex
  • Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital"
  • LLC "Scientific Research Center Eco-Safety"
  • JSC Polyclinic Complex
  • State Healthcare Institution
  • Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia
  • Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze
  • Saint Petersburg Research Institute of Emergency Medicine
  • LLC X7 Clinical Research
  • Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center"
  • Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department
  • Scientific Medical Complex "University Clinic" of Kharkiv
  • MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2
  • Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council
  • "Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City
  • Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv
  • Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv
  • Communal non-profit enterprise Kyiv City Clinical Hospital №1
  • Kyiv City Clinical Hospital of Emergency Aid,
  • Kyiv City Clinical Hospital of Emergency Aid
  • Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway"
  • National Scientific Center Institute of Cardiology of M.D
  • State Institution "National Scientific Center "Institute of Cardiology
  • Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL"
  • Medical Centre of LLC
  • MNPE "Lviv City Clinical Hospital No.5"
  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical
  • Vinnytsia Regional Clinical Hospital of Veterans of War
  • "Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology"
  • Communal Non-Profit Enterprise "City
  • Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine,
  • Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
  • Communal Enterprise "Hospital №1" of Zhytomyr City Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ferric Carboxymaltose

Placebo

Arm Description

Ferric Carboxymaltose 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1500mg - repeated every 6 months as indicated by the results of iron indices.

Normal saline 15ml - 2 doses 7 days apart repeated every 6 months.

Outcomes

Primary Outcome Measures

Incidence of death
Incidence of hospitalization for heart failure
Change in 6MWT distance

Secondary Outcome Measures

Full Information

First Posted
January 25, 2017
Last Updated
April 24, 2023
Sponsor
American Regent, Inc.
Collaborators
Duke Clinical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03037931
Brief Title
Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency
Acronym
HEART-FID
Official Title
A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
February 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.
Collaborators
Duke Clinical Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency
Detailed Description
This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) distance for patients in heart failure with iron deficiency. After an initial screening period of up to 28 days, eligible participants will be stratified by region and randomized in a 1:1 ratio to FCM or placebo for treatment. Study drug administration will occur on Day 0 and Day 7 (±2) as an undiluted slow IV push, with additional study visits planned at 3 month intervals, and additional dosing administered every 6 months as applicable. In a subset of sites, a sub-study will be conducted to characterize serum phosphate levels over time in participants with heart failure and iron deficiency after dosing with FCM. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Iron-deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3065 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric Carboxymaltose
Arm Type
Active Comparator
Arm Description
Ferric Carboxymaltose 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1500mg - repeated every 6 months as indicated by the results of iron indices.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline 15ml - 2 doses 7 days apart repeated every 6 months.
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose
Other Intervention Name(s)
Injectafer, Ferinject
Intervention Description
Intravenous Iron
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline solution
Intervention Description
Normal Saline Solution
Primary Outcome Measure Information:
Title
Incidence of death
Time Frame
1 year
Title
Incidence of hospitalization for heart failure
Time Frame
1 year
Title
Change in 6MWT distance
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (≥18 years of age) able to provide signed, written informed consent. Stable heart failure (NYHA II-IV) on maximally-tolerated background therapy (as determined by the site Principle Investigator) for at least 2 weeks prior to randomization. Able and willing to perform a 6MWT at the time of randomization. Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical intervention including coronary artery bypass graft (CABG), valvular repair/replacement, or cardiac resynchronization therapy (CRT) device implantation. a. Left ventricular ejection fraction ≤ 40% obtained during the screening visit OR either of the following i. Historical value of ejection fraction ≤ 40% within 24 months of screening visit ii. Historical value of ejection fraction ≤ 30% within 36 months of screening visit Hemoglobin >9.0 g/dL and < 13.5 g/dL (females) or <15.0 g/dL (males) within 28 days of randomization. Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%.Patients with screening ferritin <15 ng/mL must have documentation of an appropriate evaluation, as determined by the Principle Investigator, within 3 months of screening and prior to randomization. Either documented hospitalization for heart failure within 12 months of enrollment or elavated N-terminal-pro-brain natriuretic peptide (NT-proBNP) within 90 days of randomization. a. For patients in normal sinus rhythm: N-terminal-pro-brain natriuretic peptide (NT- proBNP) > 600 pg/mL (or BNP >200 pg/mL) . b . For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP >400 pg/mL) . Exclusion Criteria: Known hypersensitivity reaction to any component of FCM. History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment. Uncorrected severe aortic stenosis, severe valvular regurgitation (except mitral regurgitation due to left ventricular dilatation without planned intervention), or left ventricular outflow obstruction requiring intervention. Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest). Current or planned mechanical circulatory support or heart transplantation. Hemodialysis or peritoneal dialysis (current or planned within the next 6 months). Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range). Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia. Active gastrointestinal bleeding. Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication. Inability to return for follow up visits within the necessary windows Concurrently in a study with investigational product. No participants with Current COVID-19 Infection into the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian F Hernandez, MD
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Advanced Cardiovascular LLC
City
Alexander City
State/Province
Alabama
ZIP/Postal Code
35010
Country
United States
Facility Name
Advanced Cardiovascular, LLC
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36830
Country
United States
Facility Name
IMC/Diagnostic & Medical Clinic
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Alaska Heart & Vascular Institute
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Verde Valley Medical Center
City
Cottonwood
State/Province
Arizona
ZIP/Postal Code
86326
Country
United States
Facility Name
Clinical Research Institute of Arizona, LLC
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
Facility Name
Carondelet Heart and Vascular Institute - Cardiology East
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Sparks Regional Medical Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Westside Medical Associates of Los Angeles
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Carson
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
California Heart Specialists
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
First Valley Medical Group
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Healthcare Partners Affiliation Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
St. Joseph Heritage-Healthcare
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Radin Cardiovascular Medical Group, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Pasadena Clinical Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Eugene Soroka, MD Inc.
City
Port Hueneme
State/Province
California
ZIP/Postal Code
93041
Country
United States
Facility Name
VA San Diego Health Care System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Interventional Cardiology Medical Group
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
South Denver Cardiology Associates, PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
Christiana Care
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Alfieri Cardiology
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Cardiology Associates of South Florida
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Cardiovascular & Vein Center of Florida
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
St. Vincent's Healthcare - Riverside
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
St. Vincent's Healthcare - Southside Recruiting
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Empire Clinical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
ProLive Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
Cordova Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Med-Care Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
ITB Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Vista Health Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Hospital Transplant Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Cardiology Partners Clinical Research Institute
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Springfield Medical Center
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401
Country
United States
Facility Name
Broward Research Center
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
South Florida Research Solutions, LLC
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Cardiology Consultants
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
Avanza Medical Research Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Professional Health Care of Pinellas
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Indian River Medical Center
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Cardiology Partners Clinical Research Institute
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Piedmont Heart Institute - Athens
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
University Cardiology Associates, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Piedmont Heart Institute Fayetteville
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Georgia Arrhythmia Consultants and Research Institute
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Mercer University
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Atlanta Vanguard Research Institute
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30082
Country
United States
Facility Name
Saint Luke's Boise Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Mount Sinai Hospital Medical Center - Department of Cardiology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Medicoricium, LLC
City
Fairview Heights
State/Province
Illinois
ZIP/Postal Code
62208
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Franciscan Physician Network - Indiana Heart Physicians
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
St. Vincent Medical Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Indiana University Health Ball Memorial Hospital, Inc.
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Reid Physician Associates / Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Beacon Medical Group Advanced Cardiovascular Specialists
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Alexandria Cardiology Clinic
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Heart Clinic of Hammond
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Tulane Heart & Vascular Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Louisiana Heart Center
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Maine Medical Partners Maine Health Cardiology
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Anne Arundel Health System Research Institute
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
NECCR Prima Care Research, LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Western Michigan University Homer Stryker M.D. School of Medicine
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Michigan CardioVascular Institute at Covenant Medical Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Allina Health System, dba Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Cardiology Associates Research, LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
North Kansas City Hospital
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
St. Louis Heart & Vascular, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
CHI Health Research Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Red Rock Clinical Research, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Monmouth Cardiology Associates, LLC
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Englewood Health
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Advanced Heart & Vascular Institute of Hunterdon
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Saint Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
AtlantiCare Regional Medical Center
City
Pomona
State/Province
New Jersey
ZIP/Postal Code
08240
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Cardio Metabolic Institute
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
New York Presbyterian Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Trinity Medical WNY, PC
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14227
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Richmond University Medical Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-7007
Country
United States
Facility Name
Circuit Clinical
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Northtowns Cardiology, PLLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Asheville Cardiology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Duke University Heart Failure Research
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Medication Management, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Wake Forest University Health Sciences
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Duke Cardiology of Lumberton
City
Lumberton
State/Province
North Carolina
ZIP/Postal Code
28358
Country
United States
Facility Name
Monroe Biomedical Research
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Crossroads Clinical Research, Inc.
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Pinehurst Medical Clinic, Inc.
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
NC Heart & Vascular Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
WakeMed Health and Hospitals
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Trinity Health Center - Medical Arts
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Aultman Cardiology Clinical Trials
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
The MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
North Ohio Heart Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
North Ohio Heart Center
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Heart House Research Foundation
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
South Oklahoma Heart Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Penn State Health Holy Spirit Medical Center Geisinger - Cardiology
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania - Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
V.A. Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Prisma Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Self Regional Hospital Research Center
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
Carolina Heart Specialists
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
29720
Country
United States
Facility Name
Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc.
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Tennova Healthcare-Turkey Creek Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Parkway Cardiology Associates, PC
City
Oak Ridge
State/Province
Tennessee
ZIP/Postal Code
37830
Country
United States
Facility Name
Amarillo Hearth Clinical Research Institute, Inc.
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
PharmaTex Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Cardiovascular Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Southwest Family Medicine Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Health Research & Education Institute
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Heart & Vascular Associates
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
Caprock Cardiac Center Research Institute, Inc.
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Angelina Medical Research, LLC
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
North Dallas Research Associates
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
North Texas Research Associates
City
McKinney
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
South Texas Cardiovascular Consultants, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Baylor Scott & White Medical Center
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
PharmaTex Research
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
The University of Texas Health Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
Wichita Falls Heart Clinic
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
Advanced Clinical Research/Intermountain Heart Center PC
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
The University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Stroobants Cardiovascular Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Riverside Cardiology Specialists
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Carilion Medical Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Selma Medical Associates
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Heart & Vascular-Advanced Cardiac Support Program
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Providence Sacred Heart Medical Center & Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
CHI Franciscan Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Walla Walla Clinic
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Wenatchee Valley Hospital & Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
ProHealth Care Inc / Waukesha Memorial Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
SWSLHD-Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
1871
Country
Australia
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Cairns Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Core Research Group
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
SA Heart
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Lyell McEwin Hospital
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Heart Lung Clinic
City
Darlinghurst
State/Province
Sydney
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Macquarie University - Clinical Trials Unit
City
Macquarie Park
ZIP/Postal Code
2109
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton Heights
ZIP/Postal Code
2305
Country
Australia
Facility Name
Epworth HealthCare Clinical Trials
City
Richmond
ZIP/Postal Code
3121
Country
Australia
Facility Name
MHAT Puls
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment: Department of cardiology
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
MHAT Haskovo AD
City
Haskovo
ZIP/Postal Code
6304
Country
Bulgaria
Facility Name
Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology
City
Lom
ZIP/Postal Code
3600
Country
Bulgaria
Facility Name
Medical Center Medconsult Pleven OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
МC Hipokrena
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Second Medical Center-Sofia, EEOD - Department of Cardiology
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Second Multiprofile Hospital for Active Treatment
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
5th City Hospital
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
National Multiprofile Transport Hospital Cardiology Clinic
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Medical Center Hera EOOD - Office of Cardiology
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Facility Name
Multiprofile Regional Hospital for Active Treatment
City
Veliko Tarnovo
ZIP/Postal Code
5002
Country
Bulgaria
Facility Name
Medical Center Velingrad 2017" EOOD, Office of Cardiology
City
Velingrad
ZIP/Postal Code
4600
Country
Bulgaria
Facility Name
University of Calbary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
South Edmonton Cardiology Consultants
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 6K3
Country
Canada
Facility Name
Royal Alexandria Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Fraser Clinical Trials
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
SMH Cardiology Clinical Trials
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 1M7
Country
Canada
Facility Name
Victoria Heart Institute Foundation
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
G.A. Research Associates, Ltd.
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
Health Sciences Centre
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Manna Research Inc., Burlington South
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R 1A4
Country
Canada
Facility Name
Cambridge Cardiac Care Center
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
Vizel Cardiac Research
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7R1
Country
Canada
Facility Name
London Health Sciences Center (LHSC)
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Sinai Health System - Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Clinique de Cardiologie de Lévis
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 4Z5
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
McGill University Health Centre (MUHC)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges
City
Saint-Georges
State/Province
Quebec
ZIP/Postal Code
G5Y 4T8
Country
Canada
Facility Name
Recherche Medical St-Jerome Inc.
City
Saint-Jérôme
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Interni kardiologicka klinika FN Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Kardiologicka ambulance
City
Chlumec Nad Cidlinou
ZIP/Postal Code
50353
Country
Czechia
Facility Name
Centrum preventivní kardiologie, Karlovo nám. 32,
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Centrum preventivní kardiologie
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
General University Hospital in Prague
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
General University Hospital
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
IKEM-Klinika kardiologie
City
Prague
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
JSC Evex Hospitals,Georgia
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Facility Name
Clinic-LJ
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Name
Aleksandre Aladashvili Clinic LLC
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Facility Name
Ltd Israel-Georgian Medical Research Clinic "Helsicore"
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Ltd Pineo Medical Ecosistem
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
Acad. G. Chapidze Emergency Cardiology Center
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Bokhua Memorial Cardiovascular Center
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Ltd TIM- Tbilisi Institute of Medicine
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Georgian-Dutch Hospital
City
Tbilisi
ZIP/Postal Code
0172
Country
Georgia
Facility Name
Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ Kardiológiai Osztály
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Clinexpert Gyöngyös Kft
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház
City
Harkány
ZIP/Postal Code
7815
Country
Hungary
Facility Name
Bács-Kiskun Megyei Kórház Kardiológiai Osztály
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Andrea Hornyik, MD
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika,
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Belvárosi Egészségház Kft
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
LV5417
Country
Latvia
Facility Name
Liepajas Regional Hospital
City
Liepaja
ZIP/Postal Code
LV3414
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
Riga East University hospital clinic Gailezers
City
Riga
ZIP/Postal Code
LV1038
Country
Latvia
Facility Name
The Hospital of Lithuanian
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Klaipeda Seaman's Hospital
City
Klaipėda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Wellington Hospital
City
Newton
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Totara Clinical Research, Health New Lynn
City
Auckland
ZIP/Postal Code
0600
Country
New Zealand
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Middlemore Hospital
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Christchurch Heart Institute
City
Christchurch
ZIP/Postal Code
8140
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Hauora Tairāwhiti Department of Cardiology
City
Gisborne
ZIP/Postal Code
4010
Country
New Zealand
Facility Name
Hawke's Bay Hospital
City
Hastings
ZIP/Postal Code
4120
Country
New Zealand
Facility Name
Hutt Hospital
City
Lower Hutt
ZIP/Postal Code
5010
Country
New Zealand
Facility Name
Nelson Hospital
City
Nelson
ZIP/Postal Code
7010
Country
New Zealand
Facility Name
Taranaki Base Hospital
City
New Plymouth
ZIP/Postal Code
4310
Country
New Zealand
Facility Name
Rotorua Hospital
City
Rotorua
Country
New Zealand
Facility Name
Clinical Horizons NEW ZEALAND LTD
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Oddział Kardiologii WSzS nr 4
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Biokinetica S.A. Przychodnia Józefów
City
Józefów
ZIP/Postal Code
05-410
Country
Poland
Facility Name
Centrum Medyczne Linden
City
Kraków
ZIP/Postal Code
30-394
Country
Poland
Facility Name
1 Wojskowy Szpital Klininiczny w Lublinie
City
Lublin
ZIP/Postal Code
20-049
Country
Poland
Facility Name
Ko-Med Centra Kliniczne
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Szpital Swietej Anny w Miechowie
City
Miechów
ZIP/Postal Code
32-200
Country
Poland
Facility Name
Szpital Świętej Anny w Miechowie
City
Miechów
ZIP/Postal Code
32-200
Country
Poland
Facility Name
Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna
City
Nowy Dwór Mazowiecki
ZIP/Postal Code
05-100
Country
Poland
Facility Name
Zespol Opieki Zdrowotnej
City
Oława
ZIP/Postal Code
55-200
Country
Poland
Facility Name
Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Centrum Medyczne K2J2
City
Wołomin
ZIP/Postal Code
05-200
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Facility Name
4th Military Hospital
City
Wrocław
ZIP/Postal Code
50-981
Country
Poland
Facility Name
Proximum Centrum Usług Medycznych NZOZ
City
Wrocław
ZIP/Postal Code
53-428
Country
Poland
Facility Name
Marcin Ogórek, MD, PhD
City
Łódź
ZIP/Postal Code
94-048
Country
Poland
Facility Name
Municipal Autonomous Healthcare Institution "City Clinical Hospital #6
City
Chelyabinsk
ZIP/Postal Code
454017
Country
Russian Federation
Facility Name
Municipal Autonomous Healthcare Institution
City
Chelyabinsk
ZIP/Postal Code
454017
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Moscow city "Moscow
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Private Medical Institution "Euromedservice
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
State Budgetary Institution of Ryazan Region
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
JSC Polyclinic Complex
City
Saint Petersburg
ZIP/Postal Code
190013
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital"
City
Saint Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
LLC "Scientific Research Center Eco-Safety"
City
Saint Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
JSC Polyclinic Complex
City
Saint-Petersburg
ZIP/Postal Code
190013
Country
Russian Federation
Facility Name
State Healthcare Institution
City
Saratov
ZIP/Postal Code
410002
Country
Russian Federation
Facility Name
Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze
City
St. Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Saint Petersburg Research Institute of Emergency Medicine
City
St. Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
LLC X7 Clinical Research
City
St. Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center"
City
Ivano-Frankivs'k
ZIP/Postal Code
76025
Country
Ukraine
Facility Name
Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
Scientific Medical Complex "University Clinic" of Kharkiv
City
Kharkiv
ZIP/Postal Code
61157
Country
Ukraine
Facility Name
MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council
City
Kryvyi Rih
ZIP/Postal Code
50031
Country
Ukraine
Facility Name
"Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City
City
Kyiv,
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv
City
Kyiv
ZIP/Postal Code
01103
Country
Ukraine
Facility Name
Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Communal non-profit enterprise Kyiv City Clinical Hospital №1
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital of Emergency Aid,
City
Kyiv
ZIP/Postal Code
02166
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital of Emergency Aid
City
Kyiv
ZIP/Postal Code
02166
Country
Ukraine
Facility Name
Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway"
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
National Scientific Center Institute of Cardiology of M.D
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
State Institution "National Scientific Center "Institute of Cardiology
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL"
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Medical Centre of LLC
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
MNPE "Lviv City Clinical Hospital No.5"
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical
City
Lviv
ZIP/Postal Code
79041
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital of Veterans of War
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
"Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology"
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Communal Non-Profit Enterprise "City
City
Zaporizhzhia
ZIP/Postal Code
69001
Country
Ukraine
Facility Name
Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine,
City
Zaporizhzhia
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Communal Enterprise "Hospital №1" of Zhytomyr City Council
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34003690
Citation
Mentz RJ, Ambrosy AP, Ezekowitz JA, Lewis GD, Butler J, Wong YW, De Pasquale CG, Troughton RW, O'Meara E, Rockhold FW, Garg J, Samsky MD, Leloudis D, Dugan M, Mundy LM, Hernandez AF; HEART-FID Trial Investigators. Randomized Placebo-Controlled Trial of Ferric Carboxymaltose in Heart Failure With Iron Deficiency: Rationale and Design. Circ Heart Fail. 2021 May;14(5):e008100. doi: 10.1161/CIRCHEARTFAILURE.120.008100. Epub 2021 May 18.
Results Reference
derived

Learn more about this trial

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency

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