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 - BAY 1067197 in stable HFpatients on standard therapy

Bayer0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•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

•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

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