Trial Condition(s):

Chronic heart failure with preserved ejection fraction

Patient-reported outcomes in vericiguat-treated patients with HFpEF (VITALITY-HFpEF)

Bayer Identifier:

19334

ClinicalTrials.gov Identifier:

NCT03547583

EudraCT Number:

2018-000298-65

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
789
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Vericiguat (BAY1021189)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

PACE Cardiology Clinic

Newmarket, Canada, L3Y 2P6

Status
Completed
 
Locations

Oakville Cardiologists, Inc.

Oakville, Canada, L6K 3W7

Status
Completed
 
Locations

UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

AZ St-Jan Brugge Oostende AV

BRUGGE, Belgium, 8000

Status
Completed
 
Locations

AZ Delta

ROESELARE, Belgium, 8800

Status
Completed
 
Locations

H. Hartziekenhuis Mol

MOL, Belgium, 2400

Status
Completed
 
Locations

Algemeen Stedelijk Ziekenhuis Campus Aalst

AALST, Belgium, 9300

Status
Completed
 
Locations

Hospital da Luz - Lisboa

Lisboa, Portugal, 1500-650

Status
Completed
 
Locations

CHTS - Hospital Padre Americo

Guilhufe, Portugal, 4564-007

Status
Completed
 
Locations

Complejo Hospitalario Ntra. Sra. de Valme

Sevilla, Spain, 41014

Status
Completed
 
Locations

Hospital Virgen de la Victoria

Málaga, Spain, 29010

Status
Completed
 
Locations

Hospital Sanitas La Zarzuela

Aravaca, Spain, 28023

Status
Completed
 
Locations

Hospital Universitario Clinica Puerta de Hierro

Majadahonda, Spain, 28222

Status
Completed
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
Completed
 
Locations

Hospital Álvaro Cunqueiro

Babio - Beade, Spain, 36312

Status
Completed
 
Locations

Hospital Sant Joan Despi Moises Broggi

Sant Joan Despi, Spain, 08940

Status
Completed
 
Locations

Centro de Especialidades Médicas

Villa Luro, Argentina, C1440CFD

Status
Completed
 
Locations

Wake Forest Baptist Health

Winston Salem, United States, 27157

Status
Completed
 
Locations

Henry Ford Health System

Detroit, United States, 48202

Status
Completed
 
Locations

St. Louis Heart & Vascular, PC

St. Louis, United States, 63136

Status
Completed
 
Locations

Interventional Cardiology Medical Group

West Hills, United States, 91307

Status
Completed
 
Locations

Clinique Sante Cardio MC

Montreal, Canada, H1T 3Y7

Status
Completed
 
Locations

London Health Sciences Centre

London, Canada, N6A 5A5

Status
Completed
 
Locations

Centre De Recherche Du (CRCHUM) - Hotel-Diu

Montreal, Canada, H2X 3H8

Status
Completed
 
Locations

SMH Cardiology Clinical Trials Inc

Surrey, Canada, V3V 0C6

Status
Completed
 
Locations

CardioVasc HR, Inc.

Saint-Jean-sur-Richelieu, Canada, J3A 1J2

Status
Completed
 
Locations

Clínica DIM

Ramos Mejía, Argentina, B1740ETD

Status
Completed
 
Locations

National Heart Centre Singapore

Singapore, Singapore, 169609

Status
Completed
 
Locations

Singapore General Hospital

Singapore, Singapore, 169608

Status
Completed
 
Locations

Klinikum der Universität Würzburg

Würzburg, Germany, 97078

Status
Completed
 
Locations

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany, 41063

Status
Completed
 
Locations

Klinische Forschung Dresden GmbH

Dresden, Germany, 01069

Status
Completed
 
Locations

Zentrum für Klinische Studien Südbrandenburg GmbH

Elsterwerda, Germany, 04910

Status
Completed
 
Locations

Cardiologicum Hamburg - Praxen Wandsbek

Hamburg, Germany, 22041

Status
Completed
 
Locations

Marienhaus Klinikum Mainz

Mainz, Germany, 55131

Status
Completed
 
Locations

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127

Status
Completed
 
Locations

ASST Spedali Civili di Brescia

Brescia, Italy, 25123

Status
Completed
 
Locations

A.O.U. di Sassari

Sassari, Italy, 07100

Status
Completed
 
Locations

ASST Grande Ospedale Metropolitano Niguarda

Milano, Italy, 20162

Status
Completed
 
Locations

A.O.U. di Bologna Policlinico S.Orsola Malpighi

Bologna, Italy, 40138

Status
Completed
 
Locations

IRCCS Fondazione Policlinico San Matteo

Pavia, Italy, 27100

Status
Completed
 
Locations

A.O.U. di Ferrara

Ferrara, Italy, 44124

Status
Completed
 
Locations

ASL ROMA 6

Roma, Italy, 00040

Status
Completed
 
Locations

MHAT Sveta Marina EAD

Varna, Bulgaria, 9010

Status
Completed
 
Locations

NMTH Tzar Boris III

Sofia, Bulgaria, 1233

Status
Completed
 
Locations

Specialized Hospital for Actrive Treatm of Card - Pleven

Pleven, Bulgaria, 5800

Status
Completed
 
Locations

Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik

Pernik, Bulgaria, 2300

Status
Completed
 
Locations

Second Medical Center Sofia EOOD

Sofia, Bulgaria, 1202

Status
Completed
 
Locations

Multiprofile Hospital for Active Treatment Pazardzhik

Pazardzhik, Bulgaria, 4400

Status
Completed
 
Locations

MHAT "Knyaginya Klementina - Sofia"EAD

Sofia, Bulgaria, 1233

Status
Completed
 
Locations

MHAT Dr. Bratan Shukerov AD

Smolyan, Bulgaria, 4700

Status
Completed
 
Locations

Multiprofile Hospital for Active Treatment Medline Clinic

Plovdiv, Bulgaria, 4000

Status
Completed
 
Locations

CHLO - Hospital Sao Francisco Xavier

Lisboa, Portugal, 1449-005

Status
Completed
 
Locations

CHUP - Hospital Santo Antonio

Porto, Portugal, 4099-001

Status
Completed
 
Locations

CHS - Hospital Sao Bernardo

Setubal, Portugal, 2900-446

Status
Completed
 
Locations

Hospital de Cascais

Alcabideche, Portugal, 2755-009

Status
Completed
 
Locations

Hospital Garcia de Orta

Almada, Portugal, 2801-951

Status
Completed
 
Locations

Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)

Bad Oeynhausen, Germany, 32545

Status
Completed
 
Locations

Cardiology Partners

Wellington, United States, 33449

Status
Completed
 
Locations

East Coast Institute for Research, LLC

St. Augustine, United States, 32086

Status
Completed
 
Locations

WestSide Medical

Beverly Hills, United States, 90211

Status
Completed
 
Locations

Capitol Interventional Cardiology

Carmichael, United States, 95608

Status
Completed
 
Locations

Cardiovascular CRO Ltd.

Sudbury, Canada, P3E 5M4

Status
Completed
 
Locations

St. Michael's Hospital Health Centre

Toronto, Canada, M5B 1W8

Status
Completed
 
Locations

Anne Arundel Health System

Annapolis, United States, 21401

Status
Completed
 
Locations

Carolina Heart Specialists

Lancaster, United States, 29720

Status
Completed
 
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Universitätsklinikum St. Pölten

St. Pölten, Austria, 3100

Status
Completed
 
Locations

Bryan Heart

Lincoln, United States, 68506

Status
Terminated
 
Locations

Fox Valley Clinical Research Center, LLC

Aurora, United States, 60506

Status
Completed
 
Locations

Penrose-St. Francis Health Services

Colorado Springs, United States, 80923

Status
Completed
 
Locations

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina, S3000FWO

Status
Completed
 
Locations

Sanatorio Parque S.A.

Rosario, Argentina, S2000DSV

Status
Completed
 
Locations

Inst. de Cardiología de Corrientes Juana Francisca Cabral

Corrientes, Argentina, 3400

Status
Completed
 
Locations

Instituto de Investigaciones Clínicas San Nicolás

San Nicolás, Argentina, B2900DMH

Status
Completed
 
Locations

IPS Centro Cientifico Asistencial S.A.S

Barranquilla, Colombia

Status
Completed
 
Locations

Caja de Compensación Familiar CAFAM

Bogotá, Colombia, 0

Status
Terminated
 
Locations

Fundación Cardiovascular de Colombia

Floridablanca, Colombia

Status
Completed
 
Locations

Hospital General de Medellin

Medellin, Colombia

Status
Completed
 
Locations

Taipei Veterans General Hospital

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Szpital Kliniczny Przemienienia Panskiego

Poznan, Poland, 61-848

Status
Completed
 
Locations

IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ

Wroclaw, Poland, 50-981

Status
Completed
 
Locations

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland, 70-240

Status
Completed
 
Locations

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-156

Status
Completed
 
Locations

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Bydgoszcz, Poland, 85-681

Status
Completed
 
Locations

Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej

Wroclaw, Poland, 54-049

Status
Completed
 
Locations

SPZOZ Centralny Szpital Kliniczny UM w Lodzi

Lodz, Poland, 92-213

Status
Completed
 
Locations

Uniwersyteckie Centrum Kliniczne Warszawskiego UM

Warszawa, Poland, 02-097

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland, 15-276

Status
Completed
 
Locations

Zentrum f. klinische Studien Dr. Hanusch GmbH

Wien, Austria, 1060

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria, 4020

Status
Completed
 
Locations

Klinik Floridsdorf - Krankenhaus Nord

Wien, Austria, 1210

Status
Completed
 
Locations

Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

Budapest, Hungary

Status
Completed
 
Locations

Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

Budapest, Hungary, 1134

Status
Completed
 
Locations

Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.

Nyiregyhaza, Hungary, 4400

Status
Completed
 
Locations

Kanizsai Dorottya Hospital

Nagykanizsa, Hungary, 8800

Status
Completed
 
Locations

Budai Irgalmasrendi Korhaz

Budapest, Hungary, 1027

Status
Completed
 
Locations

Pharma4Trial Kft.

Gyongyos, Hungary, 3200

Status
Completed
 
Locations

G. GENNIMATAS General State Hospital of Athens

Athens, Greece, 11527

Status
Completed
 
Locations

Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA

Nea Ionia / Athens, Greece, 142 33

Status
Completed
 
Locations

KAT General Hospital of Athens

Kifisia / Athens, Greece, 14561

Status
Completed
 
Locations

University General Hospital of Larissa

Larissa, Greece, 41100

Status
Completed
 
Locations

Hippokration General Hospital of Thessaloniki

Thessaloniki, Greece, 54642

Status
Completed
 
Locations

“AHEPA” University General Hospital of Thessaloniki

Thessaloniki, Greece, 54636

Status
Completed
 
Locations

Glacier View Research Institute

Kalispell, United States, 59901

Status
Completed
 
Locations

Krankenhaus St. Josef Braunau

Braunau, Austria, 5280

Status
Completed
 
Locations

Centro de Investigaciones Clínicas

Buenos Aires, Argentina, C1425DES

Status
Completed
 
Locations

Shamir Medical Center (Assaf Harofeh)

Zrifin, Israel, 7030000

Status
Completed
 
Locations

Kaplan Medical Center

Rehovot, Israel, 7610001

Status
Completed
 
Locations

Rambam Health Corporation

Haifa, Israel, 3109601

Status
Completed
 
Locations

Hillel Yaffe Medical Center

Hadera, Israel, 3810101

Status
Completed
 
Locations

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Chaim Sheba Medical Center

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

Clalit Health Services through HaEmek Medical Center

Afula, Israel, 1834111

Status
Completed
 
Locations

The Baruch Padeh Medical Center, Poriya

Tiberias, Israel, 1528001

Status
Completed
 
Locations

Health Corporation of the Ziv Medical Center (R.A.)

Zefat, Israel, 1311001

Status
Completed
 
Locations

Capital Area Research, LLC

Camp Hill, United States, 17011

Status
Completed
 
Locations

Research Integrity, LLC

Owensboro, United States, 42303

Status
Completed
 
Locations

Reid Health

Richmond, United States, 47374

Status
Completed
 
Locations

Cardiology Associates Research Company

Daytona Beach, United States, 32117

Status
Completed
 
Locations

Southwest Florida Research

Naples, United States, 34102

Status
Completed
 
Locations

Fukui Prefectural Hospital

Fukui, Japan, 910-8526

Status
Completed
 
Locations

Osaka General Medical Center

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Minamino Cardiovascular Hospital

Hachioji, Japan, 192-0918

Status
Completed
 
Locations

Iwate Prefectural Central Hospital

Morioka, Japan, 020-0066

Status
Completed
 
Locations

Toho University Omori Medical Center

Ota-ku, Japan, 143-8541

Status
Completed
 
Locations

Higashi Takarazuka Satoh Hospital

Takarazuka, Japan, 665-0873

Status
Completed
 
Locations

National Hospital Organization Hamada Medical Center

Hamada, Japan, 697-8511

Status
Completed
 
Locations

Toyama Prefectural Central Hospital

Toyama, Japan, 930-8550

Status
Completed
 
Locations

University of Alberta

Edmonton, Canada, T6G 2B7

Status
Completed
 
Locations

Cardiology Associates of Fairfield County, PC

Trumbull, United States, 06611

Status
Completed
 
Locations

Heart Clinic of Hammond

Hammond, United States, 70403

Status
Completed
 
Locations

Stern Cardiovascular Center

Germantown, United States, 38138

Status
Completed
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 100

Status
Completed
 
Locations

Far Eastern Memorial Hospital

New Taipei City, Taiwan, China, 220

Status
Completed
 
Locations

Sci-Res. Institute of Complex Cardiovascular Disorders

Kemerovo, Russia, 650002

Status
Completed
 
Locations

Research center of therapy and prophylactic medicine

Moscow, Russia, 101990

Status
Completed
 
Locations

City hospital #15

St. Petersburg, Russia, 198205

Status
Completed
 
Locations

Moscow State University n.a. M.V. Lomonosov

Moscow, Russia, 119192

Status
Completed
 
Locations

Centro de Medicina Integral e Investigacion Clínica

CABA, Argentina, C1426EGR

Status
Completed
 
Locations

Cheng Hsin General Hospital

Taipei, Taiwan, China, 112

Status
Completed
 
Locations

Cardiovascular and Vein Center of Florida

Bradenton, United States, 34209

Status
Completed
 
Locations

Durban Medical Centre

Durban, South Africa, 4067

Status
Completed
 
Locations

TREAD Research cc

Cape Town, South Africa, 7500

Status
Completed
 
Locations

Tiervlei Trial Centre

Cape Town, South Africa, 7531

Status
Completed
 
Locations

Nash Ranjith Research Centre

Merebank, South Africa, 4052

Status
Completed
 
Locations

Vergelegen Medi-Clinic

Somerset West, South Africa, 7130

Status
Completed
 
Locations

Clinical Trial Systems

Pretoria, South Africa

Status
Completed
 
Locations

Mediservis del Tolima IPS S.A.S

Ibague, Colombia

Status
Completed
 
Locations

Cardiology Associates Of South Florida PA

Boynton Beach, United States, 33472

Status
Completed
 
Locations

Sarawak Heart Centre

Sarawak, Malaysia, 94300

Status
Completed
 
Locations

Institute Jantung Negara

Kuala Lumpur, Malaysia, 50400

Status
Completed
 
Locations

Hospital Raja Perempuan Zainab II

Kelantan, Malaysia, 15200

Status
Completed
 
Locations

Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

Milano, Italy, 20089

Status
Completed
 
Locations

Advocate Condell Medical Center

Libertyville, United States, 60048

Status
Completed
 
Locations

Takatsuki Red Cross Hospital

Takatsuki, Japan, 569-1096

Status
Completed
 
Locations

Kishiwada Tokushukai Hospital

Kishiwada, Japan, 596-0042

Status
Completed
 
Locations

Tokyo Women's Medical University Hospital

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
Locations

National Hospital Organization Kanazawa Medical Center

Kanazawa, Japan, 920-8650

Status
Completed
 
Locations

Okayama Rosai Hospital

Okayama, Japan, 702-8055

Status
Completed
 
Locations

Osaka Medical College Hospital

Takatsuki, Japan, 569-8686

Status
Completed
 
Locations

Corporation Lane Research Center

Virginia Beach, United States, 23462

Status
Completed
 
Locations

LifeSpring Research Foundation, LLC

Miami, United States, 33130

Status
Completed
 
Locations

Matsuda Cardiovascular clinic

Sapporo, Japan, 003-0026

Status
Completed
 
Locations

Hirakata kohsai Hospital

Hirakata, Japan, 573-0153

Status
Completed
 
Locations

National Hospital Organization Kobe Medical Center

Kobe, Japan, 654-0155

Status
Completed
 
Locations

Seikeikai New Tokyo Heart Clinic

Matsudo, Japan, 271-0077

Status
Completed
 
Locations

Uji-Tokushukai Medical Center

Uji, Japan, 611-0041

Status
Completed
 
Locations

Steel Memorial Yawata Hospital

Kitakyushu, Japan, 805-8508

Status
Completed
 
Locations

Clinical Advancement Center, PLLC

San Antonio, United States, 78212-4740

Status
Completed
 
Locations

City Pokrovskaya Hospital

St. Petersburg, Russia, 199106

Status
Completed
 
Locations

Samara Regional Clinical Cardiology Dispensary n.a. Polyakov

Samara, Russia, 443070

Status
Completed
 
Locations

Riser Medical Associates

Picayune, United States, 39466

Status
Completed
 
Locations

National Hospital Organization Iwakuni Clinical Center

Iwakuni, Japan, 740-8510

Status
Completed
 

Trial Design