A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
- Conditions
- Heart Failure
- Interventions
- Drug: Neladenoson bialanate (BAY1067197)Drug: Placebo
- Registration Number
- NCT02992288
- Lead Sponsor
- Bayer
- Brief Summary
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 427
- Men or women aged 18 years and older
- Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class II-IV, LVEF ≤ 35% and elevated NT-proBNP
- Acute de-novo heart failure
- Requirement of any intravenous (IV) treatments following 48 hours prior to randomization
- Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
- Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neladenoson bialanate (BAY1067197) (10 mg) Neladenoson bialanate (BAY1067197) Chronic heart failure with reduced ejection fraction Neladenoson bialanate (BAY1067197) (5 mg) Neladenoson bialanate (BAY1067197) Chronic heart failure with reduced ejection fraction Neladenoson bialanate (BAY1067197) (20 mg) Neladenoson bialanate (BAY1067197) Chronic heart failure with reduced ejection fraction Neladenoson bialanate (BAY1067197) (30 mg) Neladenoson bialanate (BAY1067197) Chronic heart failure with reduced ejection fraction Neladenoson bialanate (BAY1067197) (40 mg) Neladenoson bialanate (BAY1067197) Chronic heart failure with reduced ejection fraction Placebo Placebo Chronic heart failure with reduced ejection fraction
- Primary Outcome Measures
Name Time Method Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography Baseline, Week 20 Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20 Baseline, Week 20 NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20 Baseline, Week 20 LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.
Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20 Baseline, Week 20 LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.
Number of Participants With Composite Efficacy Outcome Baseline up to Week 26 Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.
Number of Participants With Cardiovascular (CV) Mortality Baseline up to Week 26 Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.
Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20 Baseline, Week 20 High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.
Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF) Baseline up to Week 26 Number of participants with HF hospitalization and urgent visits for HF were reported.
Trial Locations
- Locations (75)
East Texas Cardiology
🇺🇸Houston, Texas, United States
Specialized Hospital for Actrive Treatm of Card - Pleven
🇧🇬Pleven, Bulgaria
NMTH Tzar Boris III
🇧🇬Sofia, Bulgaria
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
🇩🇪Bad Oeynhausen, Nordrhein-Westfalen, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
🇩🇪Ludwigshafen, Rheinland-Pfalz, Germany
KAT General Hospital of Athens
🇬🇷Kifisia / Athens, Attica, Greece
AZ Turnhout
🇧🇪Turnhout, Belgium
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
🇧🇬Pernik, Bulgaria
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
🇧🇬Sofia, Bulgaria
MHAT Dr Stefan Cherkezov
🇧🇬Veliko Tarnovo, Bulgaria
Multiprofile Hospital for Active Treatment Sveta Sofia
🇧🇬Sofia, Bulgaria
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Lombardia, Italy
AUSL 8 Arezzo
🇮🇹Arezzo, Toscana, Italy
National Hospital Organization Takasaki General Medical C
🇯🇵Takasaki, Gunma, Japan
R.I.A.C Naha City Hospital
🇯🇵Naha, Okinawa, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Southwest Florida Research
🇺🇸Naples, Florida, United States
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
St.-Johannes-Hospital Dortmund
🇩🇪Dortmund, Nordrhein-Westfalen, Germany
G. Gennimatas General State Hospital of Athens
🇬🇷Athens, Greece
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
National hospital Organization Mito Medical Center
🇯🇵Higashiibaraki, Ibaraki, Japan
Kishiwada Tokushukai Hospital
🇯🇵Kishiwada, Osaka, Japan
Grand Hôpital de Charleroi
🇧🇪Gilly, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Rambam Health Corporation
🇮🇱Haifa, Israel
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Lazio, Italy
Minamino Cardiovascular Hospital
🇯🇵Hachioji, Tokyo, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
A.O.U. Policlinico Federico II Napoli
🇮🇹Napoli, Campania, Italy
Medizinische Hochschule Hannover (MHH)
🇩🇪Hannover, Niedersachsen, Germany
Hadassah University Hospital Mount Scopus
🇮🇱Jerusalem, Israel
Hyogo Prefectural Amagasaki General Medical Center
🇯🇵Amagasaki, Hyogo, Japan
Takatsuki Red Cross Hospital
🇯🇵Takatsuki, Osaka, Japan
Charité Campus Virchow-Klinikum (CVK)
🇩🇪Berlin, Germany
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Nihon University Itabashi Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruña, Spain
ASST Spedali Civili di Brescia
🇮🇹Brescia, Lombardia, Italy
IRCCS Centro Cardiologico Fondazione Monzino
🇮🇹Milano, Lombardia, Italy
Toyama Prefectural Central Hospital
🇯🇵Toyama, Japan
St. Elizabeth Youngstown Hospital
🇺🇸Youngstown, Ohio, United States
Glacier View Research Institute-Cardiology
🇺🇸Kalispell, Montana, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Twoja Przychodnia - Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
AZ St-Jan Brugge Oostende AV
🇧🇪Brugge, Belgium
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
St. Louis Heart & Vascular, PC
🇺🇸Saint Louis, Missouri, United States
KLIMED Marek Klimkiewicz
🇵🇱Bialystok, Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o.
🇵🇱Katowice, Poland
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
🇬🇷Nea Ionia / Athens, Greece
Hippokration General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Nzoz Salus
🇵🇱Lodz, Poland
Szpital Kliniczny Przemienienia Panskiego
🇵🇱Poznan, Poland
Hospital Universitario "Virgen de la Arrixaca"
🇪🇸El Palmar, Murcia, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
🇵🇱Wroclaw, Poland
Hospital Clínico Universitario San Carlos
🇪🇸Madrid, Spain
Ziekenhuis Rijnstate
🇳🇱Arnhem, Netherlands
Szpital Specjalistyczny im. J. Dietla
🇵🇱Krakow, Poland
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Tennessee Center for Clinical Trials
🇺🇸Tullahoma, Tennessee, United States
Kliniken Maria Hilf GmbH
🇩🇪Mönchengladbach, Nordrhein-Westfalen, Germany
Thriassio General Hospital of Elefsina
🇬🇷Elefsina, Greece
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Assaf Harofeh Medical Center
🇮🇱Zrifin, Israel
Okayama Rosai Hospital
🇯🇵Okayama, Japan