AzTrials
AzTrials

Chronic Heart Failure With Preserved Ejection FractionPhase 2VITALITY-HFpEFNCT03547583

Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

A Phase 2 study testing Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets in people with Chronic Heart Failure With Preserved Ejection Fraction, run by Bayer at 177 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
789 participants
Where
177 sitesin 21 countries
Study dates
15 Jun 2018to 4 Nov 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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 locations and contacts

177 sites in 21 countries.

177 sites in 21 countries

United States29 sites

  • Anne Arundel Health System

    Annapolis, Maryland, 21401

  • Fox Valley Clinical Research Center, LLC

    Aurora, Illinois, 60506

  • WestSide Medical

    Beverly Hills, California, 90211

  • Cardiology Associates Of South Florida PA

    Boynton Beach, Florida, 33472

  • Cardiovascular and Vein Center of Florida

    Bradenton, Florida, 34209

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Capitol Interventional Cardiology

    Carmichael, California, 95608

  • Penrose-St. Francis Health Services

    Colorado Springs, Colorado, 80923

  • Cardiology Associates Research Company

    Daytona Beach, Florida, 32117

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Stern Cardiovascular Center

    Germantown, Tennessee, 38138

  • Heart Clinic of Hammond

    Hammond, Louisiana, 70403

  • Glacier View Research Institute

    Kalispell, Montana, 59901

  • Carolina Heart Specialists

    Lancaster, South Carolina, 29720

  • Advocate Condell Medical Center

    Libertyville, Illinois, 60048

  • Bryan Heart

    Lincoln, Nebraska, 68506

  • LifeSpring Research Foundation, LLC

    Miami, Florida, 33130

  • Southwest Florida Research

    Naples, Florida, 34102

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

  • Riser Medical Associates

    Picayune, Mississippi, 39466

  • Reid Health

    Richmond, Indiana, 47374

  • East Coast Institute for Research, LLC

    Saint Augustine, Florida, 32086

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212-4740

  • St. Louis Heart & Vascular, PC

    St Louis, Missouri, 63136

  • Cardiology Associates of Fairfield County, PC

    Trumbull, Connecticut, 06611

  • Corporation Lane Research Center

    Virginia Beach, Virginia, 23462

  • Cardiology Partners

    Wellington, Florida, 33449

  • Interventional Cardiology Medical Group

    West Hills, California, 91307

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan21 sites

  • Fukui Prefectural Hospital

    Fukui, 910-8526

  • Minamino Cardiovascular Hospital

    Hachiōji, Tokyo, 192-0918

  • National Hospital Organization Hamada Medical Center

    Hamada, Shimane, 697-8511

  • Hirakata kohsai Hospital

    Hirakata, Osaka, 573-0153

  • National Hospital Organization Iwakuni Clinical Center

    Iwakuni, Yamaguchi, 740-8510

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 920-8650

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka, 596-0042

  • Steel Memorial Yawata Hospital

    Kitakyushu, Fukuoka, 805-8508

  • National Hospital Organization Kobe Medical Center

    Kobe, Hyōgo, 654-0155

  • Seikeikai New Tokyo Heart Clinic

    Matsudo, Chiba, 271-0077

  • Iwate Prefectural Central Hospital

    Morioka, Iwate, 020-0066

  • Okayama Rosai Hospital

    Okayama, 702-8055

  • Osaka General Medical Center

    Osaka, 558-8558

  • Toho University Omori Medical Center

    Ōta-ku, Tokyo, 143-8541

  • Matsuda Cardiovascular clinic

    Sapporo, Hokkaido, 003-0026

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666

  • Higashi Takarazuka Satoh Hospital

    Takarazuka, Hyōgo, 665-0873

  • Takatsuki Red Cross Hospital

    Takatsuki, Osaka, 569-1096

  • Osaka Medical College Hospital

    Takatsuki, Osaka, 569-8686

  • Toyama Prefectural Central Hospital

    Toyama, 930-8550

  • Uji-Tokushukai Medical Center

    Uji, Kyoto, 611-0041

Other trials in Japan

Canada10 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

  • Cardiovascular CRO Ltd.

    Greater Sudbury, Ontario, P3E 5M4

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Clinique Sante Cardio MC

    Montreal, Quebec, H1T 3Y7

  • Centre De Recherche Du (CRCHUM) - Hotel-Diu

    Montreal, Quebec, H2X 3H8

  • PACE Cardiology Clinic

    Newmarket, Ontario, L3Y 2P6

  • Oakville Cardiologists, Inc.

    Oakville, Ontario, L6K 3W7

  • CardioVasc HR, Inc.

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

  • SMH Cardiology Clinical Trials Inc

    Surrey, British Columbia, V3V 0C6

  • St. Michael's Hospital Health Centre

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Bulgaria9 sites

  • Multiprofile Hospital for Active Treatment Pazardzhik

    Pazardzhik, 4400

  • Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik

    Pernik, 2300

  • Specialized Hospital for Actrive Treatm of Card - Pleven

    Pleven, 5800

  • Multiprofile Hospital for Active Treatment Medline Clinic

    Plovdiv, 4000

  • MHAT Dr. Bratan Shukerov AD

    Smolyan, 4700

  • Second Medical Center Sofia EOOD

    Sofia, 1202

  • NMTH Tzar Boris III

    Sofia, 1233

  • V MHAT

    Sofia, 1233

  • MHAT Sveta Marina EAD

    Varna, 9010

Other trials in Bulgaria

Israel9 sites

  • HaEmek Medical Center

    Afula, 1834111

  • Hillel Yaffe Medical Center

    Hadera, 3810101

  • Rambam Health Corporation

    Haifa, 3109601

  • Hadassah Hebrew University Hospital Ein Kerem

    Jerusalem, 9112001

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000

  • Kaplan Medical Center

    Rehovot, 7610001

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

    Safed, 1311001

  • The Baruch Padeh Medical Center, Poria

    Tiberias, 1528001

  • Shamir Medical Center (Assaf Harofeh)

    Zrifin, 7030000

Other trials in Israel

Italy9 sites

  • ASST Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

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

    Bologna, Emilia-Romagna, 40138

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123

  • A.O.U. di Ferrara

    Ferrara, Emilia-Romagna, 44124

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

    Milan, Lombardy, 20089

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Lombardy, 20162

  • IRCCS Fondazione Policlinico San Matteo

    Pavia, Lombardy, 27100

  • Asl Roma 6

    Rome, Lazio, 00040

  • A.O.U. di Sassari

    Sassari, Sardinia, 07100

Other trials in Italy

Poland9 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

    Bydgoszcz, 85-681

  • CLINICAL MEDICAL RESEARCH Sp. z o. o.

    Katowice, 40-156

  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi

    Lodz, 92-213

  • Szpital Kliniczny Przemienienia Panskiego

    Poznan, 61-848

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 70-240

  • Uniwersyteckie Centrum Kliniczne Warszawskiego UM

    Warsaw, 02-097

  • IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ

    Wroclaw, 50-981

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

    Wroclaw, 54-049

Other trials in Poland

Spain9 sites

  • Hospital Sanitas La Zarzuela

    Aravaca, Madrid, 28023

  • Hospital Álvaro Cunqueiro

    Babio - Beade, Pontevedra, 36312

  • Hospital del Mar

    Barcelona, 08003

  • Ciutat Sanitària i Universitària de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Clinica Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Sant Joan Despi Moises Broggi

    Sant Joan Despí, Barcelona, 08940

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

  • Complejo Hospitalario Ntra. Sra. de Valme

    Seville, 41014

Other trials in Spain

Argentina8 sites

  • Centro de Investigaciones Clínicas

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1425DES

  • Centro de Medicina Integral e Investigacion Clínica

    CABA, Ciudad Auton. de Buenos Aires, C1426EGR

  • Inst. de Cardiología de Corrientes Juana Francisca Cabral

    Corrientes, 3400

  • Clínica DIM

    Ramos Mejía, Buenos Aires, B1740ETD

  • Sanatorio Parque S.A.

    Rosario, Santa Fe Province, S2000DSV

  • Instituto de Investigaciones Clínicas San Nicolás

    San Nicolás de los Arroyos, Buenos Aires, B2900DMH

  • Centro de Investigaciones Clinicas del Litoral

    Santa Fe, S3000FWO

  • Centro de Especialidades Médicas

    Villa Luro, Ciudad Auton. de Buenos Aires, C1440CFD

Other trials in Argentina

Austria7 sites

  • Krankenhaus St. Josef Braunau

    Braunau am Inn, Upper Austria, 5280

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Upper Austria, 4020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, Lower Austria, 3100

  • Zentrum f. klinische Studien Dr. Hanusch GmbH

    Vienna, 1060

  • Universitätsklinikum AKH Wien

    Vienna, 1090

  • Klinik Floridsdorf - Krankenhaus Nord

    Vienna, 1210

Other trials in Austria

Germany7 sites

  • Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Klinische Forschung Dresden GmbH

    Dresden, Saxony, 01069

  • Zentrum für Klinische Studien Südbrandenburg GmbH

    Elsterwerda, Brandenburg, 04910

  • Cardiologicum Hamburg - Praxen Wandsbek

    Hamburg, 22041

  • St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, North Rhine-Westphalia, 41063

  • Klinikum der Universität Würzburg

    Würzburg, Bavaria, 97078

Other trials in Germany

Portugal7 sites

  • Hospital de Cascais

    Alcabideche, Lisbon District, 2755-009

  • Hospital Garcia de Orta

    Almada, 2801-951

  • CHTS - Hospital Padre Americo

    Guilhufe, Porto District, 4564-007

  • CHLO - Hospital Sao Francisco Xavier

    Lisbon, 1449-005

  • Hospital da Luz - Lisboa

    Lisbon, 1500-650

  • CHUP - Hospital Santo Antonio

    Porto, 4099-001

  • CHS - Hospital Sao Bernardo

    Setúbal, Setúbal District, 2900-446

Other trials in Portugal

Greece6 sites

  • G. GENNIMATAS General State Hospital of Athens

    Athens, 11527

  • KAT General Hospital of Athens

    Kifisia / Athens, Attica, 14561

  • University General Hospital of Larissa

    Larissa, 41100

  • Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA

    Nea Ionia / Athens, 142 33

  • "AHEPA" University General Hospital of Thessaloniki

    Thessaloniki, 54636

  • Hippokration General Hospital of Thessaloniki

    Thessaloniki, 54642

Other trials in Greece

Hungary6 sites

  • Budai Irgalmasrendi Korhaz

    Budapest, 1027

  • Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

    Budapest, 1134

  • Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

    Budapest

  • Pharma4Trial Kft.

    Gyöngyös, 3200

  • Kanizsai Dorottya Hospital

    Nagykanizsa, 8800

  • Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.

    Nyíregyháza, 4400

Other trials in Hungary

Russia6 sites

  • Sci-Res. Institute of Complex Cardiovascular Disorders

    Kemerovo, 650002

  • Research center of therapy and prophylactic medicine

    Moscow, 101990

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

    Moscow, 119192

  • City hospital #15

    Saint Petersburg, 198205

  • City Pokrovskaya Hospital

    Saint Petersburg, 199106

  • Samara Regional Clinical Cardiology Dispensary n.a. Polyakov

    Samara, 443070

Other trials in Russia

South Africa6 sites

  • TREAD Research cc

    Cape Town, Western Cape, 7500

  • Tiervlei Trial Centre

    Cape Town, Western Cape, 7531

  • Durban Medical Centre

    Durban, KwaZulu-Natal, 4067

  • Nash Ranjith Research Centre

    Merebank, KwaZulu-Natal, 4052

  • Clinical Trial Systems

    Pretoria, Gauteng

  • Vergelegen Medi-Clinic

    Somerset West, Western Cape, 7130

Other trials in South Africa

Belgium5 sites

  • Algemeen Stedelijk Ziekenhuis Campus Aalst

    Aalst, 9300

  • AZ St-Jan Brugge Oostende AV

    Bruges, 8000

  • UZ Antwerpen

    Edegem, 2650

  • H. Hartziekenhuis Mol

    Mol, 2400

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Colombia5 sites

  • IPS Centro Cientifico Asistencial S.A.S

    Barranquilla, Atlántico

  • Caja de Compensación Familiar CAFAM

    Bogotá, Bogota D.C., 0

  • Fundación Cardiovascular de Colombia

    Floridablanca

  • Mediservis del Tolima IPS S.A.S

    Ibague, Tolima Department

  • Hospital General de Medellin

    Medellín, Antioquia

Other trials in Colombia

Taiwan4 sites

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • National Taiwan University Hospital

    Taipei, 10016

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Cheng Hsin General Hospital

    Taipei, 112

Other trials in Taiwan

Malaysia3 sites

  • Hospital Raja Perempuan Zainab II

    Kelantan, 15200

  • Institute Jantung Negara

    Kuala Lumpur, 50400

  • Sarawak Heart Centre

    Sarawak, 94300

Other trials in Malaysia

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169608

  • National Heart Centre Singapore

    Singapore, 169609

Other trials in Singapore

About this study

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)

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.

Being tested
Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tabletsDrug

    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.

  • PlaceboDrug

    Placebo and sham up-titration at weeks 2, 4, and 6

Study groups in NCT03547583
Study groupRoleWhat they receive
Vericiguat up to 10 mgExperimentalSubjects 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.
Receives: Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
Vericiguat up to 15 mgExperimentalSubjects 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.
Receives: Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
PlaceboPlacebo comparatorSubject will receive placebo for 24 weeks, once daily, starting sham up-titration at weeks 2, 4, and 6.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline to Week 24

Secondary outcomes (1)

  1. 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.

    Measured: From baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start15 Jun 2018
  3. Primary completion15 Oct 2019
  4. Study completion4 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
789 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03547583
Sponsor's protocol ID
19334
Other IDs
2018-000298-65, 2018
Acronym
VITALITY-HFpEF
Status last verified
Nov 2020
First submitted
24 May 2018
Last updated
6 Jan 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 31096775

  • deFilippi CR, Shah P, Shah SJ, Alemayehu W, Lam CSP, Butler J, Roessig L, O'Connor CM, Westerhout CM, Armstrong PW; VITALITY-HFpEF Study Group. Proteomics Identify Clinical Phenotypes and Predict Functional Outcomes in Heart Failure With Preserved Ejection Fraction: Insights From VITALITY-HFpEF. Circ Heart Fail. 2024 Sep;17(9):e011792. doi: 10.1161/CIRCHEARTFAILURE.124.011792. Epub 2024 Aug 29.

    PubMed 39206547

  • Kaul P, Rathwell S, Lam CSP, Westerhout CM, Spertus JA, Anstrom KJ, Blaustein RO, Ezekowitz JA, Pieske B, Roessig L, Butler J, Armstrong PW; VITALITY-HFpEF Study Group. Patient-Reported Frailty and Functional Status in Heart Failure With Preserved Ejection Fraction: Insights From VITALITY-HFpEF. JACC Heart Fail. 2023 Apr;11(4):392-403. doi: 10.1016/j.jchf.2022.11.015. Epub 2023 Feb 1.

    PubMed 36881394

  • 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.

    PubMed 33079152

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets in people with Chronic Heart Failure With Preserved Ejection Fraction, run by Bayer at 177 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, Japan, Canada, Bulgaria, Israel and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in KCCQ Physical Limitation Score From Baseline to Week 24 (time frame: From baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03547583, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.

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