Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency (HEART-FID)
Heart Failure, Iron-deficiency
About this trial
This is an interventional treatment trial for Heart Failure
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.
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
Active Comparator
Placebo Comparator
Ferric Carboxymaltose
Placebo
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.