A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
- Conditions
- Heart Failure
- Interventions
- Drug: Neladenoson bialanate (BAY1067197)Drug: Placebo
- Registration Number
- NCT03098979
- Lead Sponsor
- Bayer
- Brief Summary
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 305
- Men or women aged 45 years and older
- Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV, LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP
- Acute decompensated heart failure within the past 4 weeks
- Inability to exercise
- Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF < 40%)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neladenoson bialanate (BAY1067197) (5 mg) Neladenoson bialanate (BAY1067197) Chronic heart failure with preserved ejection fraction Neladenoson bialanate (BAY1067197) (10 mg) Neladenoson bialanate (BAY1067197) Chronic heart failure with preserved ejection fraction Neladenoson bialanate (BAY1067197) (20 mg) Neladenoson bialanate (BAY1067197) Chronic heart failure with preserved ejection fraction Neladenoson bialanate (BAY1067197) (30 mg) Neladenoson bialanate (BAY1067197) Chronic heart failure with preserved ejection fraction Neladenoson bialanate (BAY1067197) (40 mg) Neladenoson bialanate (BAY1067197) Chronic heart failure with preserved ejection fraction Placebo Placebo Chronic heart failure with preserved ejection fraction
- Primary Outcome Measures
Name Time Method Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment Baseline, and up to 20 weeks of treatment The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.
- Secondary Outcome Measures
Name Time Method Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks Baseline, and up to 20 weeks of treatment High sensitivity troponin T (hs-TNT) was measured
Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score Baseline, and up to 20 weeks of treatment The KCCQ is the leading health-related quality-of-life measure for patients with chronic heart failure (CHF). It is a 23-item questionnaire that independently measures the impact of patient's heart failure (HF), or its treatment, on 7 distinct domains: 1) Symptom Frequency 2) Symptom Burden 3) Physical Limitation 4) Quality of Life 5) Social Limitations 6) Self-efficacy 7) Symptoms Stability.
Overall summary score= mean score of (symptom frequency + symptom burden+ physical limitation + quality of life + social limitation); scores on a scale of 0 to 100, higher scores means better outcome; Physical Limitation: scores on a scale of 0 to 100, higher scores means better outcome; Total symptom score=mean score of (symptom frequency + symptom burden): scores on a scale of 0 to 100, higher scores means better outcome.
Positive change means improvement and negative change means deterioration.Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity Baseline, and up to 20 weeks of treatment AVIVO™ Mobile Patient Management System, a wearable wireless device worn by the subject, was used to monitor subjects' cardiovascular status. The patient's everyday physical activity e.g. duration, intensity, was also tracked by the AVIVO device. For Activity Intensity, the Unit of Measure is "percentage of maximum activity", and length of intervals is "daily".
Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks Baseline, and up to 20 weeks of treatment NT-proBNP = N-terminal pro-hormone b-type natriuretic peptide
Trial Locations
- Locations (76)
BryanLGH Medical Center East
🇺🇸Lincoln, Nebraska, United States
General Hospital of Chalkida
🇬🇷Chalkida, Greece
Krankenhaus der Elisabethinen Linz GmbH
🇦🇹Linz, Oberösterreich, Austria
KAT General Hospital of Athens
🇬🇷Kifisia / Athens, Attica, Greece
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Specialized Hospital for Actrive Treatm of Card - Pleven
🇧🇬Pleven, Bulgaria
Universitätsklinikum St. Pölten
🇦🇹St. Pölten, Niederösterreich, Austria
CHLO - Hospital São Francisco Xavier
🇵🇹Lisboa, Portugal
MCOMH Preventsia-2000
🇧🇬Stara Zagora, Bulgaria
Hospital da Luz
🇵🇹Lisboa, Portugal
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
G. Gennimatas General State Hospital of Athens
🇬🇷Athens, Greece
Rambam Health Corporation
🇮🇱Haifa, Israel
Hadassah University Hospital Mount Scopus
🇮🇱Jerusalem, Israel
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
Krankenhaus Hietzing
🇦🇹Wien, Austria
Northwestern University
🇺🇸Chicago, Illinois, United States
St. Louis Heart & Vascular, PC
🇺🇸Saint Louis, Missouri, United States
Krankenhaus St. Josef Braunau
🇦🇹Braunau, Oberösterreich, Austria
Allgemeines Krankenhaus der Stadt Wien
🇦🇹Wien, Austria
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
CHR de la Citadelle
🇧🇪Liege, Belgium
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
🇧🇬Pernik, Bulgaria
AZ Delta
🇧🇪Roeselare, Belgium
Medical Center Cardiohelp
🇧🇬Sofia, Bulgaria
NMTH Tzar Boris III
🇧🇬Sofia, Bulgaria
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
🇧🇬Sofia, Bulgaria
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Sachsen, Germany
St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany
HELIOS Klinikum Erfurt GmbH
🇩🇪Erfurt, Thüringen, Germany
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
🇬🇷Nea Ionia / Athens, Greece
Hippokration General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Asklipieion General Hospital of Voulas
🇬🇷Voula, Greece
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
AAS 3 Friuli Alto Medio Collin
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Assaf Harofeh Medical Center
🇮🇱Zrifin, Israel
ASST Spedali Civili di Brescia
🇮🇹Brescia, Lombardia, Italy
A.O.U. Sant'Andrea
🇮🇹Roma, Lazio, Italy
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Lombardia, Italy
A.O. Ordine Mauriziano
🇮🇹Torino, Piemonte, Italy
AUSL Toscana Sud-Est
🇮🇹Arezzo, Toscana, Italy
A.O.U. di Sassari
🇮🇹Sassari, Sardegna, Italy
Hyogo Prefectural Amagasaki General Medical Center
🇯🇵Amagasaki, Hyogo, Japan
Chuno kosei Hospital
🇯🇵Seki, Gifu, Japan
Shonan Fujisawa Tokushukai Hospital
🇯🇵Fujisawa, Kanagawa, Japan
R.I.A.C Naha City Hospital
🇯🇵Naha, Okinawa, Japan
National Hospital Organization Kanazawa Medical Center
🇯🇵Kanazawa, Ishikawa, Japan
Kishiwada Tokushukai Hospital
🇯🇵Kishiwada, Osaka, Japan
Osaka Medical College Hospital
🇯🇵Takatsuki, Osaka, Japan
Takatsuki Red Cross Hospital
🇯🇵Takatsuki, Osaka, Japan
Minamino Cardiovascular Hospital
🇯🇵Hachioji, Tokyo, Japan
Fukui Prefectural Hospital
🇯🇵Fukui, Japan
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Okayama Rosai Hospital
🇯🇵Okayama, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Tokushima Prefectural Central Hospital
🇯🇵Tokushima, Japan
Szpital Zachodni w Grodzisku Mazowieckim
🇵🇱Grodzisk Mazowiecki, Poland
Szpital Specjalistyczny im. J. Dietla
🇵🇱Krakow, Poland
109 Szpital Wojskowy z przychodnia SPZOZ
🇵🇱Szczecin, Poland
Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego
🇵🇱Lodz, Poland
Szpital Wolski im. dr Anny Gostynskiej SPZOZ
🇵🇱Warszawa, Poland
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
🇵🇱Wroclaw, Poland
CHUP, EPE - Hospital de Santo Antonio
🇵🇹Porto, Portugal
CHUC - Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Hospital Universitario "Virgen de la Arrixaca"
🇪🇸El Palmar, Murcia, Spain
Hospital Sanitas La Zarzuela
🇪🇸Aravaca, Madrid, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Clínico Universitario San Carlos
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Charité Campus Virchow-Klinikum (CVK)
🇩🇪Berlin, Germany