A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction (PANTHEON)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Chronic Heart Failure, Heart Failure with Reduced Ejection Fraction
Eligibility Criteria
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
Sites / Locations
- Southwest Florida Research
- Henry Ford Health System
- University of Mississippi Medical Center
- St. Louis Heart & Vascular, PC
- Glacier View Research Institute-Cardiology
- Stony Brook University Medical Center
- St. Elizabeth Youngstown Hospital
- Tennessee Center for Clinical Trials
- East Texas Cardiology
- AZ St-Jan Brugge Oostende AV
- Grand Hôpital de Charleroi
- AZ Delta
- AZ Turnhout
- Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
- Specialized Hospital for Actrive Treatm of Card - Pleven
- NMTH Tzar Boris III
- UMHAT Tsaritsa Joanna-ISUL EAD Sofia
- Multiprofile Hospital for Active Treatment Sveta Sofia
- MHAT Dr Stefan Cherkezov
- Medizinische Hochschule Hannover (MHH)
- Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
- St.-Johannes-Hospital Dortmund
- Kliniken Maria Hilf GmbH
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH
- Charité Campus Virchow-Klinikum (CVK)
- KAT General Hospital of Athens
- G. Gennimatas General State Hospital of Athens
- Thriassio General Hospital of Elefsina
- Konstantopoulio General Hospital of Nea Ionia - Agia Olga
- Hippokration General Hospital of Thessaloniki
- Barzilai Medical Center
- Hillel Yaffe Medical Center
- Rambam Health Corporation
- Shaare Zedek Medical Center
- Hadassah University Hospital Mount Scopus
- Tel-Aviv Sourasky Medical Center
- Assaf Harofeh Medical Center
- A.O.U. Policlinico Federico II Napoli
- Fondazione Policlinico Universitario Agostino Gemelli
- ASST Papa Giovanni XXIII
- ASST Spedali Civili di Brescia
- IRCCS Centro Cardiologico Fondazione Monzino
- AUSL 8 Arezzo
- Gunma University Hospital
- National Hospital Organization Takasaki General Medical C
- Hyogo Prefectural Amagasaki General Medical Center
- National hospital Organization Mito Medical Center
- R.I.A.C Naha City Hospital
- Kishiwada Tokushukai Hospital
- Takatsuki Red Cross Hospital
- Minamino Cardiovascular Hospital
- Nihon University Itabashi Hospital
- Tokyo Women's Medical University Hospital
- Hiroshima University Hospital
- Okayama Rosai Hospital
- Osaka General Medical Center
- Toyama Prefectural Central Hospital
- Onze Lieve Vrouwe Gasthuis
- Ziekenhuis Rijnstate
- Universitair Medisch Centrum Groningen
- Erasmus Medisch Centrum
- KLIMED Marek Klimkiewicz
- CLINICAL MEDICAL RESEARCH Sp. z o. o.
- Szpital Specjalistyczny im. J. Dietla
- Nzoz Salus
- Szpital Kliniczny Przemienienia Panskiego
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
- IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
- Hospital Clínico Universitario de Santiago de Compostela
- Hospital Universitario "Virgen de la Arrixaca"
- Complejo Hospitalario Universitario A Coruña
- Hospital General Universitario Gregorio Marañón
- Hospital Clínico Universitario San Carlos
- Hospital Clínico Universitario de Valencia
- Hospital Universitari i Politècnic La Fe
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Neladenoson bialanate (BAY1067197) (5 mg)
Neladenoson bialanate (BAY1067197) (10 mg)
Neladenoson bialanate (BAY1067197) (20 mg)
Neladenoson bialanate (BAY1067197) (30 mg)
Neladenoson bialanate (BAY1067197) (40 mg)
Placebo
Chronic heart failure with reduced ejection fraction
Chronic heart failure with reduced ejection fraction
Chronic heart failure with reduced ejection fraction
Chronic heart failure with reduced ejection fraction
Chronic heart failure with reduced ejection fraction
Chronic heart failure with reduced ejection fraction