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 fractio

Phase 2

Completed

Conditions: Chronic Heart Failure
Heart Failure with reduced Ejection Fraction (HFrEF)
10019280

Registration Number: NL-OMON47145

Lead Sponsor: Bayer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Men or women aged 18 years and older
2. Diagnosis of chronic heart failure (CHF), NYHA class II-IV, LVEF * 35% and Elevated NT-proBNP

Exclusion Criteria

1. Acute de-novo heart failure
2. Requirement of any intravenous (IV) treatments following 48 hours prior to randomization:
3 Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
4. Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Absolute change from baseline in left ventricular ejection fraction (LVEF; %)<br /><br>after 20 weeks<br /><br>Absolute change from baseline in log-transformed NT-proBNP (N-terminal<br /><br>pro-hormone b-type natriuretic peptide ) (pg/mL) after 20 weeks</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Left ventricular end-systolic volume (LVESV, ml) at 20 weeks of treatment. Key<br /><br>echocardiographic parameter, measured values and absolute change from baseline<br /><br>at 20 weeks<br /><br>Left ventricular end-diastolic volume (LVEDV, ml) at 20 weeks of treatment. Key<br /><br>echocardiographic parameter, measured values and absolute change from baseline<br /><br>at 20 weeks<br /><br>High sensitivity troponin T (hs-TNT; ng/L), measured values (log transformed)<br /><br>and absolute / relative change from baseline at 20 weeks as a biomarker of<br /><br>myocardial injury<br /><br>Clinical outcomes at 20 weeks of treatment measured by cardiovascular (CV)<br /><br>mortality, heart failure (HF) hospitalization and urgent visits for HF</p><br>