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)
Bayer Identifier:
15128
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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 | |
|---|---|
Locations AZ St-Jan Brugge Oostende AV BRUGGE, Belgium, 8000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AZ Delta ROESELARE, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Grand Hôpital de Charleroi GILLY, Belgium, 6060 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UMHAT Tsaritsa Joanna-ISUL EAD Sofia Sofia, Bulgaria, 1527 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NMTH Tzar Boris III Sofia, Bulgaria, 1233 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MHAT Dr Stefan Cherkezov Veliko Tarnovo, Bulgaria, 5000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AZ Turnhout TURNHOUT, Belgium, 2300 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Specialized Hospital for Actrive Treatm of Card - Pleven Pleven, Bulgaria, 5800 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik Pernik, Bulgaria, 2300 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Multiprofile Hospital for Active Treatment Sveta Sofia Sofia, Bulgaria, 1618 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) Bad Oeynhausen, Germany, 32545 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medizinische Hochschule Hannover (MHH) Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kliniken Maria Hilf GmbH Mönchengladbach, Germany, 41063 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St.-Johannes-Hospital Dortmund Dortmund, Germany, 44137 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen, Germany, 67063 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations G. Gennimatas General State Hospital of Athens Athens, Greece, 11527 | 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 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations KAT General Hospital of Athens Kifisia / Athens, Greece, 14561 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hippokration General Hospital of Thessaloniki Thessaloniki, Greece, 54642 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Thriassio General Hospital of Elefsina Elefsina, Greece, 19018 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations East Texas Cardiology Houston, United States, 77002 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tennessee Center for Clinical Trials Tullahoma, United States, 37388 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Henry Ford Health System Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Glacier View Research Institute-Cardiology Kalispell, United States, 59901 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Mississippi Medical Center Jackson, United States, 39216 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Louis Heart & Vascular, PC St. Louis, United States, 63136 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Stony Brook University Medical Center Stony Brook, United States, 11794 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Assaf Harofeh Medical Center Zrifin, Israel, 6093000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Barzilai Medical Center Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shaare Zedek Medical Center Jerusalem, Israel, 9103102 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hillel Yaffe Medical Center Hadera, Israel, 3810101 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hadassah University Hospital Mount Scopus Jerusalem, Israel | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Spedali Civili di Brescia Brescia, Italy, 25123 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IRCCS Centro Cardiologico Fondazione Monzino Milano, Italy, 20138 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AUSL 8 Arezzo Arezzo, Italy, 52040 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. Policlinico Federico II Napoli Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario "Virgen de la Arrixaca" El Palmar, Spain, 30120 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital General Universitario Gregorio Marañón Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitair Medisch Centrum Groningen GRONINGEN, Netherlands, 9700 RB | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Erasmus Medisch Centrum ROTTERDAM, Netherlands, 3015 CE | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Onze Lieve Vrouwe Gasthuis AMSTERDAM, Netherlands, 1091 AC | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NZOZ SALUS Lodz, Poland, 91-302 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations KLIMED Marek Klimkiewicz Bialystok, Poland, 15-776 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ Wroclaw, Poland, 50-981 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Specjalistyczny im. J. Dietla Krakow, Poland, 31-121 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Kliniczny Przemienienia Panskiego Poznan, Poland, 61-848 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin, Poland, 71-434 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-139 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Complejo Hospitalario Universitario A Coruña A Coruña, Spain, 15006 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Southwest Florida Research Naples, United States, 34102 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Takatsuki Red Cross Hospital Takatsuki, Japan, 569-1096 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Toyama Prefectural Central Hospital Toyama, Japan, 930-8550 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations R.I.A.C Naha City Hospital Naha, Japan, 902-8511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-8522 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ziekenhuis Rijnstate ARNHEM, Netherlands, 6815 AD | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Elizabeth Youngstown Hospital Youngstown, United States, 44501 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hyogo Prefectural Amagasaki General Medical Center Amagasaki, Japan, 660-8550 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nihon University Itabashi Hospital Itabashi-ku, Japan, 173-8610 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National hospital Organization Mito Medical Center Higashiibaraki, Japan, 311-3193 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Minamino Cardiovascular Hospital Hachioji, Japan, 192-0918 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Okayama Rosai Hospital Okayama, Japan, 702-8055 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hiroshima University Hospital Hiroshima, Japan, 734-8511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Takasaki General Medical C Takasaki, Japan, 370-0829 | 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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