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

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	6/7/2018
Start Date:	February 22, 2017
End Date:	May 16, 2018

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

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

We found this trial at

sites

Stony Brook University Medical Center

101 Nicolls Rd
Stony Brook, New York 11794

(631) 444-4000