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Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF (VITALITY-HFpEF)

Primary Purpose

Chronic Heart Failure With Preserved Ejection Fraction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

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

Inclusion Criteria:

  • Previous diagnosis of chronic heart failure (HF)
  • HF decompensation within 6 months prior to randomization, defined as hospitalization for HF or intravenous (IV) diuretic treatment for HF without hospitalization.

  • N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 or brain natriuretic peptide (BNP) ≥100 pg/mL in sinus rhythm, or NT-proBNP

    ≥600 or BNP ≥200 pg/mL in atrial fibrillation within 30 days prior to randomization

  • Diagnostic criteria of HFpEF by echocardiography assessed within 12 months prior to randomization (most recent measurement must be used to determine eligibility with no interim event signaling potential deterioration in ejection fraction)

    • Left ventricular ejection fraction (LVEF) ≥45% and

    • Structural changes indicated by at least one of the following parameters:

      • Left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness ≥1.1 cm, and/or LV mass index ≥115 g/m*2 in male and ≥95 g/m*2 in female), or
      • Left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index ≥29 ml/m*2, or LAV >58 mL in male and >52 mL in female patients, or LA area >20 cm*2, or LA diameter >40 mm in male and >38 mm in female patients)
  • NYHA class II or III at randomization

Exclusion Criteria:

  • Clinical instability at randomization, defined by

    • Any IV treatment within 24h prior to randomization, and/or
    • SBP ≥160 mmHg
    • SBP <110 mmHg and/or DBP <40 mmHg and/or symptomatic hypotension
    • Resting heart rate (HR) <50 or ≥100 beats per minute (bpm)
  • Use of IV inotropes at any time between qualifying HF event and randomization
  • Previous diagnosis of reduced ejection fraction (EF) (EF <40%)
  • Hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis, or pericardial disease
  • Primary valvular heart disease requiring surgery or intervention, or within 3 months after valvular surgery or intervention, or active endocarditis
  • Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting (CABG) within 60 days prior to randomization, or indication for Percutaneous coronary intervention or CABG at the time of randomization
  • Symptomatic carotid stenosis, or transient ischemic attack or stroke within 60 days prior to randomization
  • Complex congenital heart disease

  • Non-cardiac comorbidity (any of the following)

    • Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m*2 calculated by Modification of Diet in Renal Disease formula
    • Hepatic insufficiency classified as Child-Pugh B or C
    • Morbid obesity with a body mass index >45 kg/m*2
    • Malignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment
    • Requires continuous home oxygen for severe pulmonary disease or has interstitial lung disease
    • Patients with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients
  • Concurrent or anticipated use of nitrates or NO donors, phosphodiesterase type V (PDE5) inhibitors, or a Soluble guanylate cyclase (sGC) stimulator

Sites / Locations

  • WestSide Medical
  • Capitol Interventional Cardiology
  • Interventional Cardiology Medical Group
  • Penrose-St. Francis Health Services
  • Cardiology Associates of Fairfield County, PC
  • Cardiology Associates Of South Florida PA
  • Cardiovascular and Vein Center of Florida
  • Cardiology Associates Research Company
  • LifeSpring Research Foundation, LLC
  • Southwest Florida Research
  • East Coast Institute for Research, LLC
  • Cardiology Partners
  • Fox Valley Clinical Research Center, LLC
  • Advocate Condell Medical Center
  • Reid Health
  • Research Integrity, LLC
  • Heart Clinic of Hammond
  • Anne Arundel Health System
  • Henry Ford Health System
  • Riser Medical Associates
  • St. Louis Heart & Vascular, PC
  • Glacier View Research Institute
  • Bryan Heart
  • Wake Forest Baptist Health
  • Capital Area Research, LLC
  • Carolina Heart Specialists
  • Stern Cardiovascular Center
  • Clinical Advancement Center, PLLC
  • Corporation Lane Research Center
  • Clínica DIM
  • Instituto de Investigaciones Clínicas San Nicolás
  • Centro de Investigaciones Clínicas
  • Centro de Medicina Integral e Investigacion Clínica
  • Centro de Especialidades Médicas
  • Sanatorio Parque S.A.
  • Inst. de Cardiología de Corrientes Juana Francisca Cabral
  • Centro de Investigaciones Clinicas del Litoral
  • Universitätsklinikum St. Pölten
  • Krankenhaus St. Josef Braunau
  • Ordensklinikum Linz GmbH Elisabethinen
  • Medizinische Universität Graz
  • Zentrum f. klinische Studien Dr. Hanusch GmbH
  • Universitätsklinikum AKH Wien
  • Klinik Floridsdorf - Krankenhaus Nord
  • Algemeen Stedelijk Ziekenhuis Campus Aalst
  • AZ St-Jan Brugge Oostende AV
  • UZ Antwerpen
  • H. Hartziekenhuis Mol
  • AZ Delta
  • Multiprofile Hospital for Active Treatment Pazardzhik
  • Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
  • Specialized Hospital for Actrive Treatm of Card - Pleven
  • Multiprofile Hospital for Active Treatment Medline Clinic
  • MHAT Dr. Bratan Shukerov AD
  • Second Medical Center Sofia EOOD
  • NMTH Tzar Boris III
  • V MHAT
  • MHAT Sveta Marina EAD
  • University of Alberta
  • SMH Cardiology Clinical Trials Inc
  • London Health Sciences Centre
  • PACE Cardiology Clinic
  • Oakville Cardiologists, Inc.
  • Cardiovascular CRO Ltd.
  • St. Michael's Hospital Health Centre
  • Clinique Sante Cardio MC
  • Centre De Recherche Du (CRCHUM) - Hotel-Diu
  • CardioVasc HR, Inc.
  • Hospital General de Medellin
  • IPS Centro Cientifico Asistencial S.A.S
  • Caja de Compensación Familiar CAFAM
  • Mediservis del Tolima IPS S.A.S
  • Fundación Cardiovascular de Colombia
  • Klinikum der Universität Würzburg
  • Zentrum für Klinische Studien Südbrandenburg GmbH
  • Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
  • Kliniken Maria Hilf GmbH
  • St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
  • Klinische Forschung Dresden GmbH
  • Cardiologicum Hamburg - Praxen Wandsbek
  • KAT General Hospital of Athens
  • G. GENNIMATAS General State Hospital of Athens
  • University General Hospital of Larissa
  • Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
  • "AHEPA" University General Hospital of Thessaloniki
  • Hippokration General Hospital of Thessaloniki
  • Budai Irgalmasrendi Korhaz
  • Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz
  • Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz
  • Pharma4Trial Kft.
  • Kanizsai Dorottya Hospital
  • Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
  • HaEmek Medical Center
  • Hillel Yaffe Medical Center
  • Rambam Health Corporation
  • Hadassah Hebrew University Hospital Ein Kerem
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • The Baruch Padeh Medical Center, Poria
  • Health Corporation of the Ziv Medical Center (R.A.)
  • Shamir Medical Center (Assaf Harofeh)
  • A.O.U. di Bologna Policlinico S.Orsola Malpighi
  • A.O.U. di Ferrara
  • Asl Roma 6
  • ASST Papa Giovanni XXIII
  • ASST Spedali Civili di Brescia
  • IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
  • ASST Grande Ospedale Metropolitano Niguarda
  • IRCCS Fondazione Policlinico San Matteo
  • A.O.U. di Sassari
  • Seikeikai New Tokyo Heart Clinic
  • Steel Memorial Yawata Hospital
  • Matsuda Cardiovascular clinic
  • National Hospital Organization Kobe Medical Center
  • Higashi Takarazuka Satoh Hospital
  • National Hospital Organization Kanazawa Medical Center
  • Iwate Prefectural Central Hospital
  • Uji-Tokushukai Medical Center
  • Hirakata kohsai Hospital
  • Kishiwada Tokushukai Hospital
  • Takatsuki Red Cross Hospital
  • Osaka Medical College Hospital
  • National Hospital Organization Hamada Medical Center
  • Minamino Cardiovascular Hospital
  • Toho University Omori Medical Center
  • Tokyo Women's Medical University Hospital
  • National Hospital Organization Iwakuni Clinical Center
  • Fukui Prefectural Hospital
  • Okayama Rosai Hospital
  • Osaka General Medical Center
  • Toyama Prefectural Central Hospital
  • Hospital Raja Perempuan Zainab II
  • Institute Jantung Negara
  • Sarawak Heart Centre
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
  • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi
  • Szpital Kliniczny Przemienienia Panskiego
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Uniwersyteckie Centrum Kliniczne Warszawskiego UM
  • IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
  • Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej
  • Hospital de Cascais
  • CHTS - Hospital Padre Americo
  • CHS - Hospital Sao Bernardo
  • Hospital Garcia de Orta
  • CHLO - Hospital Sao Francisco Xavier
  • Hospital da Luz - Lisboa
  • CHUP - Hospital Santo Antonio
  • Sci-Res. Institute of Complex Cardiovascular Disorders
  • Research center of therapy and prophylactic medicine
  • Moscow State University n.a. M.V. Lomonosov
  • Samara Regional Clinical Cardiology Dispensary n.a. Polyakov
  • City hospital #15
  • City Pokrovskaya Hospital
  • Singapore General Hospital
  • National Heart Centre Singapore
  • Clinical Trial Systems
  • Durban Medical Centre
  • Nash Ranjith Research Centre
  • TREAD Research cc
  • Tiervlei Trial Centre
  • Vergelegen Medi-Clinic
  • Hospital Clínico Universitario de Santiago de Compostela
  • Ciutat Sanitària i Universitària de Bellvitge
  • Hospital Sant Joan Despi Moises Broggi
  • Hospital Sanitas La Zarzuela
  • Hospital Universitario Clinica Puerta de Hierro
  • Hospital Álvaro Cunqueiro
  • Hospital del Mar
  • Hospital Virgen de la Victoria
  • Complejo Hospitalario Ntra. Sra. de Valme
  • Far Eastern Memorial Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Cheng Hsin General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Vericiguat up to 10 mg

Vericiguat up to 15 mg

Placebo

Arm Description

Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.

Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6.

Subject will receive placebo for 24 weeks, once daily, starting sham up-titration at weeks 2, 4, and 6.

Outcomes

Primary Outcome Measures

Change in KCCQ Physical Limitation Score From Baseline to Week 24
The City Cardiomyopathy Questionnaire (KCCQ) measures the impact of patients' heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.

Secondary Outcome Measures

Change in the Six-minute Walk Test (6MWT) From Baseline to Week 24
6MWT was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.

Full Information

First Posted
May 24, 2018
Last Updated
December 15, 2020
Sponsor
Bayer
Collaborators
Merck Sharp & Dohme LLC, Canadian VIGOUR Centre, Duke Clinical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03547583
Brief Title
Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
Acronym
VITALITY-HFpEF
Official Title
A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of the Oral sGC stImulator Vericiguat to Improve Physical Functioning in Activities of Daily Living in Patients With Heart Failure and Preserved Ejection Fraction (VITALITY-HFpEF)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Merck Sharp & Dohme LLC, Canadian VIGOUR Centre, 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 hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure With Preserved Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
789 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vericiguat up to 10 mg
Arm Type
Experimental
Arm Description
Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6.
Arm Title
Vericiguat up to 15 mg
Arm Type
Experimental
Arm Description
Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subject will receive placebo for 24 weeks, once daily, starting sham up-titration at weeks 2, 4, and 6.
Intervention Type
Drug
Intervention Name(s)
Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
Intervention Description
Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo and sham up-titration at weeks 2, 4, and 6
Primary Outcome Measure Information:
Title
Change in KCCQ Physical Limitation Score From Baseline to Week 24
Description
The City Cardiomyopathy Questionnaire (KCCQ) measures the impact of patients' heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
Time Frame
From baseline to Week 24
Secondary Outcome Measure Information:
Title
Change in the Six-minute Walk Test (6MWT) From Baseline to Week 24
Description
6MWT was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.
Time Frame
From baseline to Week 24
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment Emergent Adverse Events
Description
An AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation patient after providing written informed consent for participation in the study. Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 5 calendar days after end of treatment with study medication.
Time Frame
From first application of study drug up to 5 calendar days after end of treatment with study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previous diagnosis of chronic heart failure (HF) HF decompensation within 6 months prior to randomization, defined as hospitalization for HF or intravenous (IV) diuretic treatment for HF without hospitalization. N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 or brain natriuretic peptide (BNP) ≥100 pg/mL in sinus rhythm, or NT-proBNP ≥600 or BNP ≥200 pg/mL in atrial fibrillation within 30 days prior to randomization Diagnostic criteria of HFpEF by echocardiography assessed within 12 months prior to randomization (most recent measurement must be used to determine eligibility with no interim event signaling potential deterioration in ejection fraction) Left ventricular ejection fraction (LVEF) ≥45% and Structural changes indicated by at least one of the following parameters: Left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness ≥1.1 cm, and/or LV mass index ≥115 g/m*2 in male and ≥95 g/m*2 in female), or Left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index ≥29 ml/m*2, or LAV >58 mL in male and >52 mL in female patients, or LA area >20 cm*2, or LA diameter >40 mm in male and >38 mm in female patients) NYHA class II or III at randomization Exclusion Criteria: Clinical instability at randomization, defined by Any IV treatment within 24h prior to randomization, and/or SBP ≥160 mmHg SBP <110 mmHg and/or DBP <40 mmHg and/or symptomatic hypotension Resting heart rate (HR) <50 or ≥100 beats per minute (bpm) Use of IV inotropes at any time between qualifying HF event and randomization Previous diagnosis of reduced ejection fraction (EF) (EF <40%) Hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis, or pericardial disease Primary valvular heart disease requiring surgery or intervention, or within 3 months after valvular surgery or intervention, or active endocarditis Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting (CABG) within 60 days prior to randomization, or indication for Percutaneous coronary intervention or CABG at the time of randomization Symptomatic carotid stenosis, or transient ischemic attack or stroke within 60 days prior to randomization Complex congenital heart disease Non-cardiac comorbidity (any of the following) Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m*2 calculated by Modification of Diet in Renal Disease formula Hepatic insufficiency classified as Child-Pugh B or C Morbid obesity with a body mass index >45 kg/m*2 Malignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment Requires continuous home oxygen for severe pulmonary disease or has interstitial lung disease Patients with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients Concurrent or anticipated use of nitrates or NO donors, phosphodiesterase type V (PDE5) inhibitors, or a Soluble guanylate cyclase (sGC) stimulator
Facility Information:
Facility Name
WestSide Medical
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Capitol Interventional Cardiology
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Interventional Cardiology Medical Group
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Penrose-St. Francis Health Services
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Facility Name
Cardiology Associates of Fairfield County, PC
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Cardiology Associates Of South Florida PA
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Cardiovascular and Vein Center of Florida
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Cardiology Associates Research Company
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
LifeSpring Research Foundation, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
Southwest Florida Research
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Cardiology Partners
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Fox Valley Clinical Research Center, LLC
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60506
Country
United States
Facility Name
Advocate Condell Medical Center
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Research Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Heart Clinic of Hammond
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Anne Arundel Health System
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Riser Medical Associates
City
Picayune
State/Province
Mississippi
ZIP/Postal Code
39466
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
Glacier View Research Institute
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Bryan Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Capital Area Research, LLC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Carolina Heart Specialists
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
29720
Country
United States
Facility Name
Stern Cardiovascular Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212-4740
Country
United States
Facility Name
Corporation Lane Research Center
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Clínica DIM
City
Ramos Mejía
State/Province
Buenos Aires
ZIP/Postal Code
B1740ETD
Country
Argentina
Facility Name
Instituto de Investigaciones Clínicas San Nicolás
City
San Nicolás
State/Province
Buenos Aires
ZIP/Postal Code
B2900DMH
Country
Argentina
Facility Name
Centro de Investigaciones Clínicas
City
Buenos Aires
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1425DES
Country
Argentina
Facility Name
Centro de Medicina Integral e Investigacion Clínica
City
Caba
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1426EGR
Country
Argentina
Facility Name
Centro de Especialidades Médicas
City
Villa Luro
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1440CFD
Country
Argentina
Facility Name
Sanatorio Parque S.A.
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Inst. de Cardiología de Corrientes Juana Francisca Cabral
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
Centro de Investigaciones Clinicas del Litoral
City
Santa Fe
ZIP/Postal Code
S3000FWO
Country
Argentina
Facility Name
Universitätsklinikum St. Pölten
City
St. Pölten
State/Province
Niederösterreich
ZIP/Postal Code
3100
Country
Austria
Facility Name
Krankenhaus St. Josef Braunau
City
Braunau
State/Province
Oberösterreich
ZIP/Postal Code
5280
Country
Austria
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Zentrum f. klinische Studien Dr. Hanusch GmbH
City
Wien
ZIP/Postal Code
1060
Country
Austria
Facility Name
Universitätsklinikum AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinik Floridsdorf - Krankenhaus Nord
City
Wien
ZIP/Postal Code
1210
Country
Austria
Facility Name
Algemeen Stedelijk Ziekenhuis Campus Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
AZ St-Jan Brugge Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
H. Hartziekenhuis Mol
City
MOL
ZIP/Postal Code
2400
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Multiprofile Hospital for Active Treatment Pazardzhik
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Facility Name
Specialized Hospital for Actrive Treatm of Card - Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Medline Clinic
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT Dr. Bratan Shukerov AD
City
Smolyan
ZIP/Postal Code
4700
Country
Bulgaria
Facility Name
Second Medical Center Sofia EOOD
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
NMTH Tzar Boris III
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
V MHAT
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
MHAT Sveta Marina EAD
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
SMH Cardiology Clinical Trials Inc
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
PACE Cardiology Clinic
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P6
Country
Canada
Facility Name
Oakville Cardiologists, Inc.
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6K 3W7
Country
Canada
Facility Name
Cardiovascular CRO Ltd.
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5M4
Country
Canada
Facility Name
St. Michael's Hospital Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Clinique Sante Cardio MC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 3Y7
Country
Canada
Facility Name
Centre De Recherche Du (CRCHUM) - Hotel-Diu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3H8
Country
Canada
Facility Name
CardioVasc HR, Inc.
City
Saint-Jean-sur-Richelieu
State/Province
Quebec
ZIP/Postal Code
J3A 1J2
Country
Canada
Facility Name
Hospital General de Medellin
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
IPS Centro Cientifico Asistencial S.A.S
City
Barranquilla
State/Province
Atlántico
Country
Colombia
Facility Name
Caja de Compensación Familiar CAFAM
City
Bogotá
State/Province
Distrito Capital De Bogotá
ZIP/Postal Code
0
Country
Colombia
Facility Name
Mediservis del Tolima IPS S.A.S
City
Ibague
State/Province
Tolima
Country
Colombia
Facility Name
Fundación Cardiovascular de Colombia
City
Floridablanca
Country
Colombia
Facility Name
Klinikum der Universität Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97078
Country
Germany
Facility Name
Zentrum für Klinische Studien Südbrandenburg GmbH
City
Elsterwerda
State/Province
Brandenburg
ZIP/Postal Code
04910
Country
Germany
Facility Name
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH
City
Mönchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41063
Country
Germany
Facility Name
St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01069
Country
Germany
Facility Name
Cardiologicum Hamburg - Praxen Wandsbek
City
Hamburg
ZIP/Postal Code
22041
Country
Germany
Facility Name
KAT General Hospital of Athens
City
Kifisia / Athens
State/Province
Attica
ZIP/Postal Code
14561
Country
Greece
Facility Name
G. GENNIMATAS General State Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41100
Country
Greece
Facility Name
Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
City
Nea Ionia / Athens
ZIP/Postal Code
142 33
Country
Greece
Facility Name
"AHEPA" University General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Hippokration General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz
City
Budapest
Country
Hungary
Facility Name
Pharma4Trial Kft.
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Kanizsai Dorottya Hospital
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Hebrew University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
The Baruch Padeh Medical Center, Poria
City
Tiberias
ZIP/Postal Code
1528001
Country
Israel
Facility Name
Health Corporation of the Ziv Medical Center (R.A.)
City
Zefat
ZIP/Postal Code
1311001
Country
Israel
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Zrifin
ZIP/Postal Code
7030000
Country
Israel
Facility Name
A.O.U. di Bologna Policlinico S.Orsola Malpighi
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O.U. di Ferrara
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44124
Country
Italy
Facility Name
Asl Roma 6
City
Roma
State/Province
Lazio
ZIP/Postal Code
00040
Country
Italy
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
ASST Spedali Civili di Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
IRCCS Fondazione Policlinico San Matteo
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
A.O.U. di Sassari
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy
Facility Name
Seikeikai New Tokyo Heart Clinic
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
271-0077
Country
Japan
Facility Name
Steel Memorial Yawata Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
805-8508
Country
Japan
Facility Name
Matsuda Cardiovascular clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0026
Country
Japan
Facility Name
National Hospital Organization Kobe Medical Center
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
654-0155
Country
Japan
Facility Name
Higashi Takarazuka Satoh Hospital
City
Takarazuka
State/Province
Hyogo
ZIP/Postal Code
665-0873
Country
Japan
Facility Name
National Hospital Organization Kanazawa Medical Center
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Iwate Prefectural Central Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-0066
Country
Japan
Facility Name
Uji-Tokushukai Medical Center
City
Uji
State/Province
Kyoto
ZIP/Postal Code
611-0041
Country
Japan
Facility Name
Hirakata kohsai Hospital
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-0153
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-0042
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
National Hospital Organization Hamada Medical Center
City
Hamada
State/Province
Shimane
ZIP/Postal Code
697-8511
Country
Japan
Facility Name
Minamino Cardiovascular Hospital
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
National Hospital Organization Iwakuni Clinical Center
City
Iwakuni
State/Province
Yamaguchi
ZIP/Postal Code
740-8510
Country
Japan
Facility Name
Fukui Prefectural Hospital
City
Fukui
ZIP/Postal Code
910-8526
Country
Japan
Facility Name
Okayama Rosai Hospital
City
Okayama
ZIP/Postal Code
702-8055
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Hospital Raja Perempuan Zainab II
City
Kelantan
ZIP/Postal Code
15200
Country
Malaysia
Facility Name
Institute Jantung Negara
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Sarawak Heart Centre
City
Sarawak
ZIP/Postal Code
94300
Country
Malaysia
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
CLINICAL MEDICAL RESEARCH Sp. z o. o.
City
Katowice
ZIP/Postal Code
40-156
Country
Poland
Facility Name
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
70-240
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne Warszawskiego UM
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej
City
Wroclaw
ZIP/Postal Code
54-049
Country
Poland
Facility Name
Hospital de Cascais
City
Alcabideche
State/Province
Lisboa
ZIP/Postal Code
2755-009
Country
Portugal
Facility Name
CHTS - Hospital Padre Americo
City
Guilhufe
State/Province
Porto
ZIP/Postal Code
4564-007
Country
Portugal
Facility Name
CHS - Hospital Sao Bernardo
City
Setubal
State/Province
Setúbal
ZIP/Postal Code
2900-446
Country
Portugal
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
CHLO - Hospital Sao Francisco Xavier
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Facility Name
Hospital da Luz - Lisboa
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
CHUP - Hospital Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Sci-Res. Institute of Complex Cardiovascular Disorders
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Research center of therapy and prophylactic medicine
City
Moscow
ZIP/Postal Code
101990
Country
Russian Federation
Facility Name
Moscow State University n.a. M.V. Lomonosov
City
Moscow
ZIP/Postal Code
119192
Country
Russian Federation
Facility Name
Samara Regional Clinical Cardiology Dispensary n.a. Polyakov
City
Samara
ZIP/Postal Code
443070
Country
Russian Federation
Facility Name
City hospital #15
City
St. Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
City Pokrovskaya Hospital
City
St. Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
National Heart Centre Singapore
City
Singapore
ZIP/Postal Code
169609
Country
Singapore
Facility Name
Clinical Trial Systems
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Durban Medical Centre
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4067
Country
South Africa
Facility Name
Nash Ranjith Research Centre
City
Merebank
State/Province
Kwazulu-Natal
ZIP/Postal Code
4052
Country
South Africa
Facility Name
TREAD Research cc
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Tiervlei Trial Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7531
Country
South Africa
Facility Name
Vergelegen Medi-Clinic
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Ciutat Sanitària i Universitària de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Sant Joan Despi Moises Broggi
City
Sant Joan Despi
State/Province
Barcelona
ZIP/Postal Code
08940
Country
Spain
Facility Name
Hospital Sanitas La Zarzuela
City
Aravaca
State/Province
Madrid
ZIP/Postal Code
28023
Country
Spain
Facility Name
Hospital Universitario Clinica Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Babio - Beade
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complejo Hospitalario Ntra. Sra. de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10016
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Cheng Hsin General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31096775
Citation
Butler J, Lam CSP, Anstrom KJ, Ezekowitz J, Hernandez AF, O'Connor CM, Pieske B, Ponikowski P, Shah SJ, Solomon SD, Voors AA, Wu Y, Carvalho F, Bamber L, Blaustein RO, Roessig L, Armstrong PW. Rationale and Design of the VITALITY-HFpEF Trial. Circ Heart Fail. 2019 May;12(5):e005998. doi: 10.1161/CIRCHEARTFAILURE.119.005998.
Results Reference
background
PubMed Identifier
33079152
Citation
Armstrong PW, Lam CSP, Anstrom KJ, Ezekowitz J, Hernandez AF, O'Connor CM, Pieske B, Ponikowski P, Shah SJ, Solomon SD, Voors AA, She L, Vlajnic V, Carvalho F, Bamber L, Blaustein RO, Roessig L, Butler J; VITALITY-HFpEF Study Group. Effect of Vericiguat vs Placebo on Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The VITALITY-HFpEF Randomized Clinical Trial. JAMA. 2020 Oct 20;324(15):1512-1521. doi: 10.1001/jama.2020.15922. Erratum In: JAMA. 2021 Feb 2;325(5):494.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

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