Chronic Heart Failure With Preserved Ejection Fraction Clinical Trial
— VITALITY-HFpEFOfficial 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)
| Verified date | November 2020 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 789 |
| Est. completion date | November 4, 2019 |
| Est. primary completion date | October 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro de Investigaciones Clínicas | Buenos Aires | Ciudad Auton. De Buenos Aires |
| Argentina | Centro de Medicina Integral e Investigacion Clínica | Caba | Ciudad Auton. De Buenos Aires |
| Argentina | Inst. de Cardiología de Corrientes Juana Francisca Cabral | Corrientes | |
| Argentina | Clínica DIM | Ramos Mejía | Buenos Aires |
| Argentina | Sanatorio Parque S.A. | Rosario | Santa Fe |
| Argentina | Instituto de Investigaciones Clínicas San Nicolás | San Nicolás | Buenos Aires |
| Argentina | Centro de Investigaciones Clinicas del Litoral | Santa Fe | |
| Argentina | Centro de Especialidades Médicas | Villa Luro | Ciudad Auton. De Buenos Aires |
| Austria | Krankenhaus St. Josef Braunau | Braunau | Oberösterreich |
| Austria | Medizinische Universität Graz | Graz | Steiermark |
| Austria | Ordensklinikum Linz GmbH Elisabethinen | Linz | Oberösterreich |
| Austria | Universitätsklinikum St. Pölten | St. Pölten | Niederösterreich |
| Austria | Klinik Floridsdorf - Krankenhaus Nord | Wien | |
| Austria | Universitätsklinikum AKH Wien | Wien | |
| Austria | Zentrum f. klinische Studien Dr. Hanusch GmbH | Wien | |
| Belgium | Algemeen Stedelijk Ziekenhuis Campus Aalst | Aalst | |
| Belgium | AZ St-Jan Brugge Oostende AV | Brugge | |
| Belgium | UZ Antwerpen | Edegem | |
| Belgium | H. Hartziekenhuis Mol | MOL | |
| Belgium | AZ Delta | Roeselare | |
| Bulgaria | Multiprofile Hospital for Active Treatment Pazardzhik | Pazardzhik | |
| Bulgaria | Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik | Pernik | |
| Bulgaria | Specialized Hospital for Actrive Treatm of Card - Pleven | Pleven | |
| Bulgaria | Multiprofile Hospital for Active Treatment Medline Clinic | Plovdiv | |
| Bulgaria | MHAT Dr. Bratan Shukerov AD | Smolyan | |
| Bulgaria | NMTH Tzar Boris III | Sofia | |
| Bulgaria | Second Medical Center Sofia EOOD | Sofia | |
| Bulgaria | V MHAT | Sofia | |
| Bulgaria | MHAT Sveta Marina EAD | Varna | |
| Canada | University of Alberta | Edmonton | Alberta |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | Centre De Recherche Du (CRCHUM) - Hotel-Diu | Montreal | Quebec |
| Canada | Clinique Sante Cardio MC | Montreal | Quebec |
| Canada | PACE Cardiology Clinic | Newmarket | Ontario |
| Canada | Oakville Cardiologists, Inc. | Oakville | Ontario |
| Canada | CardioVasc HR, Inc. | Saint-Jean-sur-Richelieu | Quebec |
| Canada | Cardiovascular CRO Ltd. | Sudbury | Ontario |
| Canada | SMH Cardiology Clinical Trials Inc | Surrey | British Columbia |
| Canada | St. Michael's Hospital Health Centre | Toronto | Ontario |
| Colombia | IPS Centro Cientifico Asistencial S.A.S | Barranquilla | Atlántico |
| Colombia | Caja de Compensación Familiar CAFAM | Bogotá | Distrito Capital De Bogotá |
| Colombia | Fundación Cardiovascular de Colombia | Floridablanca | |
| Colombia | Mediservis del Tolima IPS S.A.S | Ibague | Tolima |
| Colombia | Hospital General de Medellin | Medellin | Antioquia |
| Germany | Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) | Bad Oeynhausen | Nordrhein-Westfalen |
| Germany | Klinische Forschung Dresden GmbH | Dresden | Sachsen |
| Germany | Zentrum für Klinische Studien Südbrandenburg GmbH | Elsterwerda | Brandenburg |
| Germany | Cardiologicum Hamburg - Praxen Wandsbek | Hamburg | |
| Germany | St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz | Mainz | Rheinland-Pfalz |
| Germany | Kliniken Maria Hilf GmbH | Mönchengladbach | Nordrhein-Westfalen |
| Germany | Klinikum der Universität Würzburg | Würzburg | Bayern |
| Greece | G. GENNIMATAS General State Hospital of Athens | Athens | |
| Greece | KAT General Hospital of Athens | Kifisia / Athens | Attica |
| Greece | University General Hospital of Larissa | Larissa | |
| Greece | Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA | Nea Ionia / Athens | |
| Greece | "AHEPA" University General Hospital of Thessaloniki | Thessaloniki | |
| Greece | Hippokration General Hospital of Thessaloniki | Thessaloniki | |
| Hungary | Budai Irgalmasrendi Korhaz | Budapest | |
| Hungary | Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz | Budapest | |
| Hungary | Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz | Budapest | |
| Hungary | Pharma4Trial Kft. | Gyongyos | |
| Hungary | Kanizsai Dorottya Hospital | Nagykanizsa | |
| Hungary | Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft. | Nyiregyhaza | |
| Israel | HaEmek Medical Center | Afula | |
| Israel | Hillel Yaffe Medical Center | Hadera | |
| Israel | Rambam Health Corporation | Haifa | |
| Israel | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem | |
| Israel | Chaim Sheba Medical Center | Ramat Gan | |
| Israel | Kaplan Medical Center | Rehovot | |
| Israel | The Baruch Padeh Medical Center, Poria | Tiberias | |
| Israel | Health Corporation of the Ziv Medical Center (R.A.) | Zefat | |
| Israel | Shamir Medical Center (Assaf Harofeh) | Zrifin | |
| Italy | ASST Papa Giovanni XXIII | Bergamo | Lombardia |
| Italy | A.O.U. di Bologna Policlinico S.Orsola Malpighi | Bologna | Emilia-Romagna |
| Italy | ASST Spedali Civili di Brescia | Brescia | Lombardia |
| Italy | A.O.U. di Ferrara | Ferrara | Emilia-Romagna |
| Italy | ASST Grande Ospedale Metropolitano Niguarda | Milano | Lombardia |
| Italy | IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. | Milano | Lombardia |
| Italy | IRCCS Fondazione Policlinico San Matteo | Pavia | Lombardia |
| Italy | Asl Roma 6 | Roma | Lazio |
| Italy | A.O.U. di Sassari | Sassari | Sardegna |
| Japan | Fukui Prefectural Hospital | Fukui | |
| Japan | Minamino Cardiovascular Hospital | Hachioji | Tokyo |
| Japan | National Hospital Organization Hamada Medical Center | Hamada | Shimane |
| Japan | Hirakata kohsai Hospital | Hirakata | Osaka |
| Japan | National Hospital Organization Iwakuni Clinical Center | Iwakuni | Yamaguchi |
| Japan | National Hospital Organization Kanazawa Medical Center | Kanazawa | Ishikawa |
| Japan | Kishiwada Tokushukai Hospital | Kishiwada | Osaka |
| Japan | Steel Memorial Yawata Hospital | Kitakyushu | Fukuoka |
| Japan | National Hospital Organization Kobe Medical Center | Kobe | Hyogo |
| Japan | Seikeikai New Tokyo Heart Clinic | Matsudo | Chiba |
| Japan | Iwate Prefectural Central Hospital | Morioka | Iwate |
| Japan | Okayama Rosai Hospital | Okayama | |
| Japan | Osaka General Medical Center | Osaka | |
| Japan | Toho University Omori Medical Center | Ota-ku | Tokyo |
| Japan | Matsuda Cardiovascular clinic | Sapporo | Hokkaido |
| Japan | Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo |
| Japan | Higashi Takarazuka Satoh Hospital | Takarazuka | Hyogo |
| Japan | Osaka Medical College Hospital | Takatsuki | Osaka |
| Japan | Takatsuki Red Cross Hospital | Takatsuki | Osaka |
| Japan | Toyama Prefectural Central Hospital | Toyama | |
| Japan | Uji-Tokushukai Medical Center | Uji | Kyoto |
| Malaysia | Hospital Raja Perempuan Zainab II | Kelantan | |
| Malaysia | Institute Jantung Negara | Kuala Lumpur | |
| Malaysia | Sarawak Heart Centre | Sarawak | |
| Poland | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | |
| Poland | 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ | Bydgoszcz | |
| Poland | CLINICAL MEDICAL RESEARCH Sp. z o. o. | Katowice | |
| Poland | SPZOZ Centralny Szpital Kliniczny UM w Lodzi | Lodz | |
| Poland | Szpital Kliniczny Przemienienia Panskiego | Poznan | |
| Poland | Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | |
| Poland | Uniwersyteckie Centrum Kliniczne Warszawskiego UM | Warszawa | |
| Poland | Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej | Wroclaw | |
| Poland | IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ | Wroclaw | |
| Portugal | Hospital de Cascais | Alcabideche | Lisboa |
| Portugal | Hospital Garcia de Orta | Almada | |
| Portugal | CHTS - Hospital Padre Americo | Guilhufe | Porto |
| Portugal | CHLO - Hospital Sao Francisco Xavier | Lisboa | |
| Portugal | Hospital da Luz - Lisboa | Lisboa | |
| Portugal | CHUP - Hospital Santo Antonio | Porto | |
| Portugal | CHS - Hospital Sao Bernardo | Setubal | Setúbal |
| Russian Federation | Sci-Res. Institute of Complex Cardiovascular Disorders | Kemerovo | |
| Russian Federation | Moscow State University n.a. M.V. Lomonosov | Moscow | |
| Russian Federation | Research center of therapy and prophylactic medicine | Moscow | |
| Russian Federation | Samara Regional Clinical Cardiology Dispensary n.a. Polyakov | Samara | |
| Russian Federation | City hospital #15 | St. Petersburg | |
| Russian Federation | City Pokrovskaya Hospital | St. Petersburg | |
| Singapore | National Heart Centre Singapore | Singapore | |
| Singapore | Singapore General Hospital | Singapore | |
| South Africa | Tiervlei Trial Centre | Cape Town | Western Cape |
| South Africa | TREAD Research cc | Cape Town | Western Cape |
| South Africa | Durban Medical Centre | Durban | Kwazulu-Natal |
| South Africa | Nash Ranjith Research Centre | Merebank | Kwazulu-Natal |
| South Africa | Clinical Trial Systems | Pretoria | Gauteng |
| South Africa | Vergelegen Medi-Clinic | Somerset West | Western Cape |
| Spain | Hospital Sanitas La Zarzuela | Aravaca | Madrid |
| Spain | Hospital Álvaro Cunqueiro | Babio - Beade | Pontevedra |
| Spain | Hospital del Mar | Barcelona | |
| Spain | Ciutat Sanitària i Universitària de Bellvitge | L'Hospitalet de Llobregat | Barcelona |
| Spain | Hospital Universitario Clinica Puerta de Hierro | Majadahonda | Madrid |
| Spain | Hospital Virgen de la Victoria | Málaga | |
| Spain | Hospital Sant Joan Despi Moises Broggi | Sant Joan Despi | Barcelona |
| Spain | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | A Coruña |
| Spain | Complejo Hospitalario Ntra. Sra. de Valme | Sevilla | |
| Taiwan | Far Eastern Memorial Hospital | New Taipei City | |
| Taiwan | Cheng Hsin General Hospital | Taipei | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| Taiwan | Taipei Veterans General Hospital | Taipei | |
| United States | Anne Arundel Health System | Annapolis | Maryland |
| United States | Fox Valley Clinical Research Center, LLC | Aurora | Illinois |
| United States | WestSide Medical | Beverly Hills | California |
| United States | Cardiology Associates Of South Florida PA | Boynton Beach | Florida |
| United States | Cardiovascular and Vein Center of Florida | Bradenton | Florida |
| United States | Capital Area Research, LLC | Camp Hill | Pennsylvania |
| United States | Capitol Interventional Cardiology | Carmichael | California |
| United States | Penrose-St. Francis Health Services | Colorado Springs | Colorado |
| United States | Cardiology Associates Research Company | Daytona Beach | Florida |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Stern Cardiovascular Center | Germantown | Tennessee |
| United States | Heart Clinic of Hammond | Hammond | Louisiana |
| United States | Glacier View Research Institute | Kalispell | Montana |
| United States | Carolina Heart Specialists | Lancaster | South Carolina |
| United States | Advocate Condell Medical Center | Libertyville | Illinois |
| United States | Bryan Heart | Lincoln | Nebraska |
| United States | LifeSpring Research Foundation, LLC | Miami | Florida |
| United States | Southwest Florida Research | Naples | Florida |
| United States | Research Integrity, LLC | Owensboro | Kentucky |
| United States | Riser Medical Associates | Picayune | Mississippi |
| United States | Reid Health | Richmond | Indiana |
| United States | East Coast Institute for Research, LLC | Saint Augustine | Florida |
| United States | St. Louis Heart & Vascular, PC | Saint Louis | Missouri |
| United States | Clinical Advancement Center, PLLC | San Antonio | Texas |
| United States | Cardiology Associates of Fairfield County, PC | Trumbull | Connecticut |
| United States | Corporation Lane Research Center | Virginia Beach | Virginia |
| United States | Cardiology Partners | Wellington | Florida |
| United States | Interventional Cardiology Medical Group | West Hills | California |
| United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer | Canadian VIGOUR Centre, Duke Clinical Research Institute, Merck Sharp & Dohme Corp. |
United States, Argentina, Austria, Belgium, Bulgaria, Canada, Colombia, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Taiwan,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of Participants With Treatment Emergent Adverse Events | 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. | From first application of study drug up to 5 calendar days after end of treatment with study drug | |
| Primary | 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 | 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. | From baseline to Week 24 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04944706 -
Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Preserved Ejection Fraction
|
Phase 2 |