Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker

Bayer

Status and phase

Completed

Phase 2

Conditions

Heart Failure

Treatments

Drug: Placebo (treatment 1)

Drug: BAY1067197 (treatment 2)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01945606

16718

2013-001287-34 (EudraCT Number)

Details and patient eligibility

About

This is a study to investigate the safety and tolerability of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single dose of 30 mg in addition to standard therapy including a beta-blocker. The aim of the study is to assess if a single oral dose of 30 mg BAY1067197 is well tolerated when given on top of standard therapy for heart failure, particularly ß-blocker treatment.

Enrollment

11 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Stable systolic heart failure (heart failure with reduced ejection fraction, heart failure with reduced ejection fraction [HFrEF]; New York Heart Association [NYHA] I-III) in sinus rhythm with a documented ejection fraction (EF) ≤45% within the last 3 months
Stable standard heart failure (HF) therapy including intermediate to high dose β-blocker with either ≥ 95 mg metoprolol succinate (controlled release tablet), ≥ 5mg Bisoprolol (immediate release [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
Ethnicity: White
Body mass index (BMI): above/equal 18.0 and below/equal 29.9 kg/m²
Age: 18 to 75 years (inclusive) at the first screening visit

Exclusion criteria

Biventricular pacing/active cardiac resynchronization therapy (CRT) device
Dependency on pacemaker or implantable cardioverter-defibrillator (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 chronic obstructive pulmonary disease (COPD) ≥ global initiative for chronic obstructive lung disease (GOLD) II and/or allergic asthma
Women of childbearing potential, pregnancy or breastfeeding