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

• Status: Completed
• Trial end date: 2018-05-16
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Adenosine A1 Receptor Agonists

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