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:

NCT02992288

EudraCT Number:

2016-003839-38

EU CT Number:

Not Available

Study Completed

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
427
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Neladenoson Bialanate (BAY1067197)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

AZ St-Jan Brugge Oostende AV

BRUGGE, Belgium, 8000

Status
Completed
Locations

AZ Delta

ROESELARE, Belgium, 8800

Status
Completed
Locations

Grand Hôpital de Charleroi

GILLY, Belgium, 6060

Status
Completed
Locations

UMHAT Tsaritsa Joanna-ISUL EAD Sofia

Sofia, Bulgaria, 1527

Status
Completed
Locations

NMTH Tzar Boris III

Sofia, Bulgaria, 1233

Status
Completed
Locations

MHAT Dr Stefan Cherkezov

Veliko Tarnovo, Bulgaria, 5000

Status
Completed
Locations

AZ Turnhout

TURNHOUT, Belgium, 2300

Status
Completed
Locations

Specialized Hospital for Actrive Treatm of Card - Pleven

Pleven, Bulgaria, 5800

Status
Completed
Locations

Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik

Pernik, Bulgaria, 2300

Status
Completed
Locations

Multiprofile Hospital for Active Treatment Sveta Sofia

Sofia, Bulgaria, 1618

Status
Completed
Locations

Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)

Bad Oeynhausen, Germany, 32545

Status
Completed
Locations

Medizinische Hochschule Hannover (MHH)

Hannover, Germany, 30625

Status
Completed
Locations

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany, 41063

Status
Completed
Locations

Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Completed
Locations

St.-Johannes-Hospital Dortmund

Dortmund, Germany, 44137

Status
Completed
Locations

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany, 67063

Status
Completed
Locations

G. Gennimatas General State Hospital of Athens

Athens, Greece, 11527

Status
Completed
Locations

Konstantopoulio General Hospital of Nea Ionia - Agia Olga

Nea Ionia / Athens, Greece, 142 33

Status
Completed
Locations

KAT General Hospital of Athens

Kifisia / Athens, Greece, 14561

Status
Completed
Locations

Hippokration General Hospital of Thessaloniki

Thessaloniki, Greece, 54642

Status
Completed
Locations

Thriassio General Hospital of Elefsina

Elefsina, Greece, 19018

Status
Completed
Locations

East Texas Cardiology

Houston, United States, 77002

Status
Completed
Locations

Tennessee Center for Clinical Trials

Tullahoma, United States, 37388

Status
Completed
Locations

Henry Ford Health System

Detroit, United States, 48202

Status
Completed
Locations

Glacier View Research Institute-Cardiology

Kalispell, United States, 59901

Status
Completed
Locations

University of Mississippi Medical Center

Jackson, United States, 39216

Status
Completed
Locations

St. Louis Heart & Vascular, PC

St. Louis, United States, 63136

Status
Completed
Locations

Stony Brook University Medical Center

Stony Brook, United States, 11794

Status
Completed
Locations

Assaf Harofeh Medical Center

Zrifin, Israel, 6093000

Status
Completed
Locations

Barzilai Medical Center

Ashkelon, Israel, 7830604

Status
Completed
Locations

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Status
Completed
Locations

Hillel Yaffe Medical Center

Hadera, Israel, 3810101

Status
Completed
Locations

Hadassah University Hospital Mount Scopus

Jerusalem, Israel

Status
Completed
Locations

Rambam Health Corporation

Haifa, Israel, 3109601

Status
Completed
Locations

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127

Status
Completed
Locations

ASST Spedali Civili di Brescia

Brescia, Italy, 25123

Status
Completed
Locations

IRCCS Centro Cardiologico Fondazione Monzino

Milano, Italy, 20138

Status
Completed
Locations

AUSL 8 Arezzo

Arezzo, Italy, 52040

Status
Completed
Locations

A.O.U. Policlinico Federico II Napoli

Napoli, Italy, 80131

Status
Completed
Locations

Hospital Universitario "Virgen de la Arrixaca"

El Palmar, Spain, 30120

Status
Completed
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
Locations

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Status
Completed
Locations

Universitair Medisch Centrum Groningen

GRONINGEN, Netherlands, 9700 RB

Status
Completed
Locations

Erasmus Medisch Centrum

ROTTERDAM, Netherlands, 3015 CE

Status
Completed
Locations

Onze Lieve Vrouwe Gasthuis

AMSTERDAM, Netherlands, 1091 AC

Status
Completed
Locations

NZOZ SALUS

Lodz, Poland, 91-302

Status
Completed
Locations

KLIMED Marek Klimkiewicz

Bialystok, Poland, 15-776

Status
Completed
Locations

IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ

Wroclaw, Poland, 50-981

Status
Completed
Locations

Szpital Specjalistyczny im. J. Dietla

Krakow, Poland, 31-121

Status
Completed
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
Locations

Szpital Kliniczny Przemienienia Panskiego

Poznan, Poland, 61-848

Status
Completed
Locations

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland, 71-434

Status
Completed
Locations

CLINICAL MEDICAL RESEARCH Sp. z o. o.

Katowice, Poland, 40-139

Status
Completed
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
Locations

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain, 15006

Status
Completed
Locations

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
Completed
Locations

Southwest Florida Research

Naples, United States, 34102

Status
Completed
Locations

Takatsuki Red Cross Hospital

Takatsuki, Japan, 569-1096

Status
Completed
Locations

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy, 00168

Status
Completed
Locations

Toyama Prefectural Central Hospital

Toyama, Japan, 930-8550

Status
Completed
Locations

R.I.A.C Naha City Hospital

Naha, Japan, 902-8511

Status
Completed
Locations

Kishiwada Tokushukai Hospital

Kishiwada, Japan, 596-8522

Status
Completed
Locations

Ziekenhuis Rijnstate

ARNHEM, Netherlands, 6815 AD

Status
Completed
Locations

St. Elizabeth Youngstown Hospital

Youngstown, United States, 44501

Status
Completed
Locations

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Japan, 660-8550

Status
Completed
Locations

Tokyo Women's Medical University Hospital

Shinjuku-ku, Japan, 162-8666

Status
Completed
Locations

Nihon University Itabashi Hospital

Itabashi-ku, Japan, 173-8610

Status
Completed
Locations

National hospital Organization Mito Medical Center

Higashiibaraki, Japan, 311-3193

Status
Completed
Locations

Osaka General Medical Center

Osaka, Japan, 558-8558

Status
Completed
Locations

Minamino Cardiovascular Hospital

Hachioji, Japan, 192-0918

Status
Completed
Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Status
Completed
Locations

Okayama Rosai Hospital

Okayama, Japan, 702-8055

Status
Completed
Locations

Gunma University Hospital

Maebashi, Japan, 371-8511

Status
Completed
Locations

Hiroshima University Hospital

Hiroshima, Japan, 734-8511

Status
Completed
Locations

National Hospital Organization Takasaki General Medical C

Takasaki, Japan, 370-0829

Status
Completed

Trial Design