Trial Condition(s):
Heart Failure
A trial to study neladenoson bialanate over 20 weeks in patients with chronic heart failure with reduced ejection fraction (PANTHEON)
Trial Purpose
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).
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations AZ St-Jan Brugge Oostende AV BRUGGE, Belgium, 8000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations AZ Delta ROESELARE, Belgium, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Grand Hôpital de Charleroi GILLY, Belgium, 6060 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations UMHAT Tsaritsa Joanna-ISUL EAD Sofia Sofia, Bulgaria, 1527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations NMTH Tzar Boris III Sofia, Bulgaria, 1233 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations MHAT Dr Stefan Cherkezov Veliko Tarnovo, Bulgaria, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations AZ Turnhout TURNHOUT, Belgium, 2300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Specialized Hospital for Actrive Treatm of Card - Pleven Pleven, Bulgaria, 5800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik Pernik, Bulgaria, 2300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Multiprofile Hospital for Active Treatment Sveta Sofia Sofia, Bulgaria, 1618 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) Bad Oeynhausen, Germany, 32545 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Medizinische Hochschule Hannover (MHH) Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kliniken Maria Hilf GmbH Mönchengladbach, Germany, 41063 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations St.-Johannes-Hospital Dortmund Dortmund, Germany, 44137 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen, Germany, 67063 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations G. Gennimatas General State Hospital of Athens Athens, Greece, 11527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Konstantopoulio General Hospital of Nea Ionia - Agia Olga Nea Ionia / Athens, Greece, 142 33 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations KAT General Hospital of Athens Kifisia / Athens, Greece, 14561 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hippokration General Hospital of Thessaloniki Thessaloniki, Greece, 54642 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Thriassio General Hospital of Elefsina Elefsina, Greece, 19018 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations East Texas Cardiology Houston, United States, 77002 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Tennessee Center for Clinical Trials Tullahoma, United States, 37388 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Henry Ford Health System Detroit, United States, 48202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Glacier View Research Institute-Cardiology Kalispell, United States, 59901 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations University of Mississippi Medical Center Jackson, United States, 39216 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations St. Louis Heart & Vascular, PC St. Louis, United States, 63136 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Stony Brook University Medical Center Stony Brook, United States, 11794 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Assaf Harofeh Medical Center Zrifin, Israel, 6093000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Barzilai Medical Center Ashkelon, Israel, 7830604 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Shaare Zedek Medical Center Jerusalem, Israel, 9103102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hillel Yaffe Medical Center Hadera, Israel, 3810101 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hadassah University Hospital Mount Scopus Jerusalem, Israel | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations ASST Spedali Civili di Brescia Brescia, Italy, 25123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations IRCCS Centro Cardiologico Fondazione Monzino Milano, Italy, 20138 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations AUSL 8 Arezzo Arezzo, Italy, 52040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations A.O.U. Policlinico Federico II Napoli Napoli, Italy, 80131 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital Universitario "Virgen de la Arrixaca" El Palmar, Spain, 30120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital General Universitario Gregorio Marañón Madrid, Spain, 28007 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Universitair Medisch Centrum Groningen GRONINGEN, Netherlands, 9700 RB | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Erasmus Medisch Centrum ROTTERDAM, Netherlands, 3015 CE | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Onze Lieve Vrouwe Gasthuis AMSTERDAM, Netherlands, 1091 AC | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations NZOZ SALUS Lodz, Poland, 91-302 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations KLIMED Marek Klimkiewicz Bialystok, Poland, 15-776 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ Wroclaw, Poland, 50-981 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Szpital Specjalistyczny im. J. Dietla Krakow, Poland, 31-121 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Szpital Kliniczny Przemienienia Panskiego Poznan, Poland, 61-848 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin, Poland, 71-434 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-139 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Complejo Hospitalario Universitario A Coruña A Coruña, Spain, 15006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Southwest Florida Research Naples, United States, 34102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Takatsuki Red Cross Hospital Takatsuki, Japan, 569-1096 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Fondazione Policlinico Universitario Agostino Gemelli Roma, Italy, 00168 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Toyama Prefectural Central Hospital Toyama, Japan, 930-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations R.I.A.C Naha City Hospital Naha, Japan, 902-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-8522 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Ziekenhuis Rijnstate ARNHEM, Netherlands, 6815 AD | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations St. Elizabeth Youngstown Hospital Youngstown, United States, 44501 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hyogo Prefectural Amagasaki General Medical Center Amagasaki, Japan, 660-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Nihon University Itabashi Hospital Itabashi-ku, Japan, 173-8610 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations National hospital Organization Mito Medical Center Higashiibaraki, Japan, 311-3193 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Minamino Cardiovascular Hospital Hachioji, Japan, 192-0918 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Okayama Rosai Hospital Okayama, Japan, 702-8055 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations Hiroshima University Hospital Hiroshima, Japan, 734-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 | |
Locations National Hospital Organization Takasaki General Medical C Takasaki, Japan, 370-0829 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
A multicenter, randomized, placebo-controlled, parallel group, double blind, dose-finding Phase II trial to study the efficacy, safety, pharmacokinetic and pharmacodynamic effects of the oral partial adenosine A1 receptor agonist neladenoson bialanate over 20 weeks in patients with chronic heart failure with reduced ejection fraction
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- Absolute change from baseline in LVEF (%) after 20 weeksLVEF: left ventricular ejection fractionTimeframe: At 20 weeks of treatment
- Absolute change from baseline in log-transformed NT-proBNP (pg/mL) after 20 weeksNT-proBNP: N-terminal pro-hormone b-type natriuretic peptideTimeframe: At 20 weeks of treatment
Secondary Outcome
- Left ventricular end-systolic volume (LVESV; mL)Key echocardiographic parameter, measured values and absolute change from baseline at 20 weeks.Timeframe: At 20 weeks of treatment
- Left ventricular end-diastolic volume (LVEDV; mL)Key echocardiographic parameter, measured values and absolute change from baseline at 20 weeks.Timeframe: At 20 weeks of treatment
- hs-TNT (ng/L), measured values (log transformed) and absolute / relative change from baseline at 20 weeks as a biomarker of myocardial injuryhs-TNT: High sensitivity troponin TTimeframe: At 20 weeks of treatment
- Clinical outcomesClinical outcomes measured by cardiovascular (CV) mortality, heart failure (HF) hospitalization and urgent visits for HF.Timeframe: At 20 weeks of treatment
Additional Information
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