A single blind, placebo controlled pilot study to explore the safety and tolerability of a single oral dose of 30 mg BAY 1067197 in patients with chronic heart failure on the background of preexisting beta-blocker therapy

Phase 2

Completed

• Conditions: congestive heart failure; heart failure; 10019280

• Registration Number: NL-OMON38750
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

•Stable systolic heart failure (heart failure with reduced ejection fraction, HFrEF; NYHA I-III) in sinus rhythm with a documented EF <=45% within the last 3 months;•Stable standard HF therapy including intermediate to high dose β-blocker with either >= 95 mg metoprolol succinate (controlled release tablet), >= 5mg Bisoprolol (IR-tablet) or >=5mg Nebivolol (IR tablet) for at least 4 weeks. Additional intake of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers and optional aldosterone-receptor antagonists, diuretics or digitalis is allowed;• Men or confirmed postmenopausal women (defined as being amenorrheic for longer than 2 years with an appropriate clinical profile, e.g. age appropriate and a history of vasomotor symptoms) or women without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy or hysterectomy (documented by medical report verification). Men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study and for 12 weeks after receiving the investigational medicinal product (IMP);•Male patients must agree not to act as sperm donor for 12 weeks after dosing;•Age: 18 to 75 years (inclusive) at the first screening visit;•Ethnicity: White;•Body mass index (BMI): above/equal 18.0 and below/equal 29.9 kg/m²

Exclusion Criteria

•Biventricular pacing/active CRT device;•Dependency on pacemaker or ICD device with pacemaker dependency (a paced ventricular rhythm > 5% of heart activity);•A history of relevant diseases of vital organs other than the heart, of the central nervous system or other organs;•Known hypersensitivity to the study preparations (active substances or excipients of the preparations) or to any other β-blocker;•Current or history of AV-Block > I°;•Unstable condition, indicated by requirement of IV drug (diuretic, inotrope, etc.) or NYHA IV;•Acute Coronary Syndrome (defined as unstable angina [UA], non-ST elevation myocardial infarction [NSTEMI], ST elevation myocardial infarction [STEMI]) within 3 months prior to first study drug administration;•History of asthma or COPD >= GOLD II and/or allergic asthma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• The primary outcome is the occurrence of AV-Block > I° (under therapy with<br /><br>BAY1067197 and preexisting &beta;-blocker therapy) up to 48 hours.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Evaluate the safety and tolerability of 1 day treatment with BAY 1067197 in<br /><br>heart failure patients on top of standard therapy<br /><br><br /><br>• To assess the pharmacokinetic profile of a single dose BAY 1067197 in heart<br /><br>failure patients on standard therapy<br /><br><br /><br>• Heart rate; multiple time points up to 24 hours<br /><br><br /><br>• Blood pressure; multiple time points up to 24 hours</p><br>