A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Heart Failure Clinical Trial

— PANTHEON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992288
• Other study ID #: 15128
• Secondary ID: 2016-003839-38
• Status: Completed
• Phase: Phase 2
• Start date: February 22, 2017
• Est. completion date: May 16, 2018

Study information

• Verified date: April 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: May 16, 2018
• Est. primary completion date: March 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Neladenoson bialanate (BAY1067197)
5 mg orally once daily for 20 weeks
• Neladenoson bialanate (BAY1067197)
10 mg orally once daily for 20 weeks
• Neladenoson bialanate (BAY1067197)
20 mg orally once daily for 20 weeks
• Neladenoson bialanate (BAY1067197)
30 mg orally once daily for 20 weeks
• Neladenoson bialanate (BAY1067197)
40 mg orally once daily for 20 weeks
• Placebo
Orally once daily for 20 weeks

Locations

Country	Name	City	State
Belgium	AZ St-Jan Brugge Oostende AV	Brugge
Belgium	Grand Hôpital de Charleroi	Gilly
Belgium	AZ Delta	Roeselare
Belgium	AZ Turnhout	Turnhout
Bulgaria	Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik	Pernik
Bulgaria	Specialized Hospital for Actrive Treatm of Card - Pleven	Pleven
Bulgaria	Multiprofile Hospital for Active Treatment Sveta Sofia	Sofia
Bulgaria	NMTH Tzar Boris III	Sofia
Bulgaria	UMHAT Tsaritsa Joanna-ISUL EAD Sofia	Sofia
Bulgaria	MHAT Dr Stefan Cherkezov	Veliko Tarnovo
Germany	Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)	Bad Oeynhausen	Nordrhein-Westfalen
Germany	Charité Campus Virchow-Klinikum (CVK)	Berlin
Germany	St.-Johannes-Hospital Dortmund	Dortmund	Nordrhein-Westfalen
Germany	Medizinische Hochschule Hannover (MHH)	Hannover	Niedersachsen
Germany	Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen	Rheinland-Pfalz
Germany	Kliniken Maria Hilf GmbH	Mönchengladbach	Nordrhein-Westfalen
Greece	G. Gennimatas General State Hospital of Athens	Athens
Greece	Thriassio General Hospital of Elefsina	Elefsina
Greece	KAT General Hospital of Athens	Kifisia / Athens	Attica
Greece	Konstantopoulio General Hospital of Nea Ionia - Agia Olga	Nea Ionia / Athens
Greece	Hippokration General Hospital of Thessaloniki	Thessaloniki
Israel	Barzilai Medical Center	Ashkelon
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Rambam Health Corporation	Haifa
Israel	Hadassah University Hospital Mount Scopus	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Israel	Assaf Harofeh Medical Center	Zrifin
Italy	AUSL 8 Arezzo	Arezzo	Toscana
Italy	ASST Papa Giovanni XXIII	Bergamo	Lombardia
Italy	ASST Spedali Civili di Brescia	Brescia	Lombardia
Italy	IRCCS Centro Cardiologico Fondazione Monzino	Milano	Lombardia
Italy	A.O.U. Policlinico Federico II Napoli	Napoli	Campania
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma	Lazio
Japan	Hyogo Prefectural Amagasaki General Medical Center	Amagasaki	Hyogo
Japan	Minamino Cardiovascular Hospital	Hachioji	Tokyo
Japan	National hospital Organization Mito Medical Center	Higashiibaraki	Ibaraki
Japan	Hiroshima University Hospital	Hiroshima
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Kishiwada Tokushukai Hospital	Kishiwada	Osaka
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	R.I.A.C Naha City Hospital	Naha	Okinawa
Japan	Okayama Rosai Hospital	Okayama
Japan	Osaka General Medical Center	Osaka
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku	Tokyo
Japan	National Hospital Organization Takasaki General Medical C	Takasaki	Gunma
Japan	Takatsuki Red Cross Hospital	Takatsuki	Osaka
Japan	Toyama Prefectural Central Hospital	Toyama
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Ziekenhuis Rijnstate	Arnhem
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Erasmus Medisch Centrum	Rotterdam
Poland	KLIMED Marek Klimkiewicz	Bialystok
Poland	CLINICAL MEDICAL RESEARCH Sp. z o. o.	Katowice
Poland	Szpital Specjalistyczny im. J. Dietla	Krakow
Poland	Nzoz Salus	Lodz
Poland	Szpital Kliniczny Przemienienia Panskiego	Poznan
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ	Wroclaw
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña
Spain	Hospital Universitario "Virgen de la Arrixaca"	El Palmar	Murcia
Spain	Hospital Clínico Universitario San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politècnic La Fe	Valencia
United States	Henry Ford Health System	Detroit	Michigan
United States	East Texas Cardiology	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Glacier View Research Institute-Cardiology	Kalispell	Montana
United States	Southwest Florida Research	Naples	Florida
United States	St. Louis Heart & Vascular, PC	Saint Louis	Missouri
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Tennessee Center for Clinical Trials	Tullahoma	Tennessee
United States	St. Elizabeth Youngstown Hospital	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Germany,  Greece,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography	Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.	Baseline, Week 20
Primary	Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20	NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.	Baseline, Week 20
Secondary	Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20	LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.	Baseline, Week 20
Secondary	Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20	LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.	Baseline, Week 20
Secondary	Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20	High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.	Baseline, Week 20
Secondary	Number of Participants With Composite Efficacy Outcome	Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.	Baseline up to Week 26
Secondary	Number of Participants With Cardiovascular (CV) Mortality	Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.	Baseline up to Week 26
Secondary	Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)	Number of participants with HF hospitalization and urgent visits for HF were reported.	Baseline up to Week 26

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