Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

NCT03547583 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 193342018-000298-65
• Study Type: interventional
• Target: 789
• Locations: 21 countries
• Sites: 177

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.

Conditions

Chronic Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (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.

  From baseline to Week 24

Secondary Outcomes (1)

• Change in the Six-minute Walk Test (6MWT) From Baseline to Week 24

  From baseline to Week 24

Other Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  From first application of study drug up to 5 calendar days after end of treatment with study drug

Study Arms (3)

Vericiguat up to 10 mg

EXPERIMENTAL

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.

Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets

Vericiguat up to 15 mg

EXPERIMENTAL

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.

Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets DRUG

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.

Vericiguat up to 10 mg; Vericiguat up to 15 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Merck Sharp & Dohme LLC: collaborator
• Canadian VIGOUR Centre: collaborator
• Duke Clinical Research Institute: collaborator

Study Sites (177)

WestSide Medical

Beverly Hills, California, 90211, United States

Location

Capitol Interventional Cardiology

Carmichael, California, 95608, United States

Location

Interventional Cardiology Medical Group

West Hills, California, 91307, United States

Location

Penrose-St. Francis Health Services

Colorado Springs, Colorado, 80923, United States

Location

Cardiology Associates of Fairfield County, PC

Trumbull, Connecticut, 06611, United States

Location

Cardiology Associates Of South Florida PA

Boynton Beach, Florida, 33472, United States

Location

Cardiovascular and Vein Center of Florida

Bradenton, Florida, 34209, United States

Location

Cardiology Associates Research Company

Daytona Beach, Florida, 32117, United States

Location

LifeSpring Research Foundation, LLC

Miami, Florida, 33130, United States

Location

Southwest Florida Research

Naples, Florida, 34102, United States

Location

East Coast Institute for Research, LLC

Saint Augustine, Florida, 32086, United States

Location

Cardiology Partners

Wellington, Florida, 33449, United States

Location

Fox Valley Clinical Research Center, LLC

Aurora, Illinois, 60506, United States

Location

Advocate Condell Medical Center

Libertyville, Illinois, 60048, United States

Location

Reid Health

Richmond, Indiana, 47374, United States

Location

Research Integrity, LLC

Owensboro, Kentucky, 42303, United States

Location

Heart Clinic of Hammond

Hammond, Louisiana, 70403, United States

Location

Anne Arundel Health System

Annapolis, Maryland, 21401, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Riser Medical Associates

Picayune, Mississippi, 39466, United States

Location

St. Louis Heart & Vascular, PC

St Louis, Missouri, 63136, United States

Location

Glacier View Research Institute

Kalispell, Montana, 59901, United States

Location

Bryan Heart

Lincoln, Nebraska, 68506, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Carolina Heart Specialists

Lancaster, South Carolina, 29720, United States

Location

Stern Cardiovascular Center

Germantown, Tennessee, 38138, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212-4740, United States

Location

Corporation Lane Research Center

Virginia Beach, Virginia, 23462, United States

Location

Clínica DIM

Ramos Mejía, Buenos Aires, B1740ETD, Argentina

Location

Instituto de Investigaciones Clínicas San Nicolás

San Nicolás de los Arroyos, Buenos Aires, B2900DMH, Argentina

Location

Centro de Investigaciones Clínicas

Buenos Aires, Ciudad Auton. de Buenos Aires, C1425DES, Argentina

Location

Centro de Medicina Integral e Investigacion Clínica

CABA, Ciudad Auton. de Buenos Aires, C1426EGR, Argentina

Location

Centro de Especialidades Médicas

Villa Luro, Ciudad Auton. de Buenos Aires, C1440CFD, Argentina

Location

Sanatorio Parque S.A.

Rosario, Santa Fe Province, S2000DSV, Argentina

Location

Inst. de Cardiología de Corrientes Juana Francisca Cabral

Corrientes, 3400, Argentina

Location

Centro de Investigaciones Clinicas del Litoral

Santa Fe, S3000FWO, Argentina

Location

Universitätsklinikum St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

Location

Medizinische Universität Graz

Graz, Styria, 8036, Austria

Location

Krankenhaus St. Josef Braunau

Braunau am Inn, Upper Austria, 5280, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, 4020, Austria

Location

Zentrum f. klinische Studien Dr. Hanusch GmbH

Vienna, 1060, Austria

Location

Universitätsklinikum AKH Wien

Vienna, 1090, Austria

Location

Klinik Floridsdorf - Krankenhaus Nord

Vienna, 1210, Austria

Location

Algemeen Stedelijk Ziekenhuis Campus Aalst

Aalst, 9300, Belgium

Location

AZ St-Jan Brugge Oostende AV

Bruges, 8000, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

H. Hartziekenhuis Mol

Mol, 2400, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Multiprofile Hospital for Active Treatment Pazardzhik

Pazardzhik, 4400, Bulgaria

Location

Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik

Pernik, 2300, Bulgaria

Location

Specialized Hospital for Actrive Treatm of Card - Pleven

Pleven, 5800, Bulgaria

Location

Multiprofile Hospital for Active Treatment Medline Clinic

Plovdiv, 4000, Bulgaria

Location

MHAT Dr. Bratan Shukerov AD

Smolyan, 4700, Bulgaria

Location

Second Medical Center Sofia EOOD

Sofia, 1202, Bulgaria

Location

NMTH Tzar Boris III

Sofia, 1233, Bulgaria

Location

V MHAT

Sofia, 1233, Bulgaria

Location

MHAT Sveta Marina EAD

Varna, 9010, Bulgaria

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

SMH Cardiology Clinical Trials Inc

Surrey, British Columbia, V3V 0C6, Canada

Location

Cardiovascular CRO Ltd.

Greater Sudbury, Ontario, P3E 5M4, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

PACE Cardiology Clinic

Newmarket, Ontario, L3Y 2P6, Canada

Location

Oakville Cardiologists, Inc.

Oakville, Ontario, L6K 3W7, Canada

Location

St. Michael's Hospital Health Centre

Toronto, Ontario, M5B 1W8, Canada

Location

Clinique Sante Cardio MC

Montreal, Quebec, H1T 3Y7, Canada

Location

Centre De Recherche Du (CRCHUM) - Hotel-Diu

Montreal, Quebec, H2X 3H8, Canada

Location

CardioVasc HR, Inc.

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

Location

Hospital General de Medellin

Medellín, Antioquia, Colombia

Location

IPS Centro Cientifico Asistencial S.A.S

Barranquilla, Atlántico, Colombia

Location

Caja de Compensación Familiar CAFAM

Bogotá, Bogota D.C., 0, Colombia

Location

Mediservis del Tolima IPS S.A.S

Ibagué, Tolima Department, Colombia

Location

Fundación Cardiovascular de Colombia

Floridablanca, Colombia

Location

Klinikum der Universität Würzburg

Würzburg, Bavaria, 97078, Germany

Location

Zentrum für Klinische Studien Südbrandenburg GmbH

Elsterwerda, Brandenburg, 04910, Germany

Location

Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Kliniken Maria Hilf GmbH

Mönchengladbach, North Rhine-Westphalia, 41063, Germany

Location

St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, Saxony, 01069, Germany

Location

Cardiologicum Hamburg - Praxen Wandsbek

Hamburg, 22041, Germany

Location

KAT General Hospital of Athens

Kifisia / Athens, Attica, 14561, Greece

Location

G. GENNIMATAS General State Hospital of Athens

Athens, 11527, Greece

Location

University General Hospital of Larissa

Larissa, 41100, Greece

Location

Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA

Nea Ionia / Athens, 142 33, Greece

Location

"AHEPA" University General Hospital of Thessaloniki

Thessaloniki, 54636, Greece

Location

Hippokration General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

Location

Budai Irgalmasrendi Korhaz

Budapest, 1027, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

Budapest, 1134, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

Budapest, Hungary

Location

Pharma4Trial Kft.

Gyöngyös, 3200, Hungary

Location

Kanizsai Dorottya Hospital

Nagykanizsa, 8800, Hungary

Location

Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.

Nyíregyháza, 4400, Hungary

Location

HaEmek Medical Center

Afula, 1834111, Israel

Location

Hillel Yaffe Medical Center

Hadera, 3810101, Israel

Location

Rambam Health Corporation

Haifa, 3109601, Israel

Location

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, 9112001, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

Kaplan Medical Center

Rehovot, 7610001, Israel

Location

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

Safed, 1311001, Israel

Location

The Baruch Padeh Medical Center, Poria

Tiberias, 1528001, Israel

Location

Shamir Medical Center (Assaf Harofeh)

Zrifin, 7030000, Israel

Location

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

Bologna, Emilia-Romagna, 40138, Italy

Location

A.O.U. di Ferrara

Ferrara, Emilia-Romagna, 44124, Italy

Location

Asl Roma 6

Rome, Lazio, 00040, Italy

Location

ASST Papa Giovanni XXIII

Bergamo, Lombardy, 24127, Italy

Location

ASST Spedali Civili di Brescia

Brescia, Lombardy, 25123, Italy

Location

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

Milan, Lombardy, 20089, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, 20162, Italy

Location

IRCCS Fondazione Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

A.O.U. di Sassari

Sassari, Sardinia, 07100, Italy

Location

Seikeikai New Tokyo Heart Clinic

Matsudo, Chiba, 271-0077, Japan

Location

Steel Memorial Yawata Hospital

Kitakyushu, Fukuoka, 805-8508, Japan

Location

Matsuda Cardiovascular clinic

Sapporo, Hokkaido, 003-0026, Japan

Location

National Hospital Organization Kobe Medical Center

Kobe, Hyōgo, 654-0155, Japan

Location

Higashi Takarazuka Satoh Hospital

Takarazuka, Hyōgo, 665-0873, Japan

Location

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Iwate Prefectural Central Hospital

Morioka, Iwate, 020-0066, Japan

Location

Uji-Tokushukai Medical Center

Uji, Kyoto, 611-0041, Japan

Location

Hirakata kohsai Hospital

Hirakata, Osaka, 573-0153, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, 596-0042, Japan

Location

Takatsuki Red Cross Hospital

Takatsuki, Osaka, 569-1096, Japan

Location

Osaka Medical College Hospital

Takatsuki, Osaka, 569-8686, Japan

Location

National Hospital Organization Hamada Medical Center

Hamada, Shimane, 697-8511, Japan

Location

Minamino Cardiovascular Hospital

Hachiōji, Tokyo, 192-0918, Japan

Location

Toho University Omori Medical Center

Ōta-ku, Tokyo, 143-8541, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

National Hospital Organization Iwakuni Clinical Center

Iwakuni, Yamaguchi, 740-8510, Japan

Location

Fukui Prefectural Hospital

Fukui, 910-8526, Japan

Location

Okayama Rosai Hospital

Okayama, 702-8055, Japan

Location

Osaka General Medical Center

Osaka, 558-8558, Japan

Location

Toyama Prefectural Central Hospital

Toyama, 930-8550, Japan

Location

Hospital Raja Perempuan Zainab II

Kelantan, 15200, Malaysia

Location

Institute Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Sarawak Heart Centre

Sarawak, 94300, Malaysia

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland

Location

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Bydgoszcz, 85-681, Poland

Location

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, 40-156, Poland

Location

SPZOZ Centralny Szpital Kliniczny UM w Lodzi

Lodz, 92-213, Poland

Location

Szpital Kliniczny Przemienienia Panskiego

Poznan, 61-848, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 70-240, Poland

Location

Uniwersyteckie Centrum Kliniczne Warszawskiego UM

Warsaw, 02-097, Poland

Location

IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ

Wroclaw, 50-981, Poland

Location

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

Wroclaw, 54-049, Poland

Location

Hospital de Cascais

Alcabideche, Lisbon District, 2755-009, Portugal

Location

CHTS - Hospital Padre Americo

Guilhufe, Porto District, 4564-007, Portugal

Location

CHS - Hospital Sao Bernardo

Setúbal, Setúbal District, 2900-446, Portugal

Location

Hospital Garcia de Orta

Almada, 2801-951, Portugal

Location

CHLO - Hospital Sao Francisco Xavier

Lisbon, 1449-005, Portugal

Location

Hospital da Luz - Lisboa

Lisbon, 1500-650, Portugal

Location

CHUP - Hospital Santo Antonio

Porto, 4099-001, Portugal

Location

Sci-Res. Institute of Complex Cardiovascular Disorders

Kemerovo, 650002, Russia

Location

Research center of therapy and prophylactic medicine

Moscow, 101990, Russia

Location

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

Moscow, 119192, Russia

Location

City hospital #15

Saint Petersburg, 198205, Russia

Location

City Pokrovskaya Hospital

Saint Petersburg, 199106, Russia

Location

Samara Regional Clinical Cardiology Dispensary n.a. Polyakov

Samara, 443070, Russia

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Clinical Trial Systems

Pretoria, Gauteng, South Africa

Location

Durban Medical Centre

Durban, KwaZulu-Natal, 4067, South Africa

Location

Nash Ranjith Research Centre

Merebank, KwaZulu-Natal, 4052, South Africa

Location

TREAD Research cc

Cape Town, Western Cape, 7500, South Africa

Location

Tiervlei Trial Centre

Cape Town, Western Cape, 7531, South Africa

Location

Vergelegen Medi-Clinic

Somerset West, Western Cape, 7130, South Africa

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Sant Joan Despi Moises Broggi

Sant Joan Despí, Barcelona, 08940, Spain

Location

Hospital Sanitas La Zarzuela

Aravaca, Madrid, 28023, Spain

Location

Hospital Universitario Clinica Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Álvaro Cunqueiro

Babio - Beade, Pontevedra, 36312, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

Complejo Hospitalario Ntra. Sra. de Valme

Seville, 41014, Spain

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

National Taiwan University Hospital

Taipei, 10016, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 31096775 BACKGROUND

• 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.

  PMID: 39206547 DERIVED

• 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.

  PMID: 36881394 DERIVED

• 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.

  PMID: 33079152 DERIVED

Related Links

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MeSH Terms

Interventions

vericiguat

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+)1-888-84 22937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 6, 2018
• Study Start: June 15, 2018
• Primary Completion: October 15, 2019
• Study Completion: November 4, 2019
• Last Updated: January 6, 2021
• Results First Posted: December 3, 2020

Record last verified: 2020-11

Locations

AR (8); IT (9); IL (9); RU (6); TW (4); CA (10); BE (5); BU (9); CO (5); PT (7); SG (2); PL (9); MY (3); AU (7); ZA (6); US (29); HU (6); JP (21); GR (6); ES (9); DE (7)