Pilot study to assess the safety of BAY 1067197 in stable heart failure patients on standard therapy including ß-blocker
- Conditions
- Heart failureMedDRA version: 16.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-001287-34-NL
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 11
•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 ß-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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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 ß-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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The objective of the study is to investigate the safety and tolerability of the partial adenosine A1 agonist BAY 1067197 on top of standard therapy in patients with chronic heart failure.<br> ;Secondary Objective: The secondary objective is to evaluate the pharmacokinetics and hemodynamic response to a single oral dose of BAY 1067197.;Primary end point(s): Number of patients with occurrence of AV-Block > I° up to 48 hours;Timepoint(s) of evaluation of this end point: N/A
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Pharmacokinetic profile determined by tmax up to 24 hours<br> Pharmacokinetic profile determined by t1/2 up to 22 days<br> Heart rate at multiple time points up to 24 hours<br> Blood pressure at multiple time points up to 24 hours<br> Number of participants with adverse events as a measure of safety and tolerability up to 48 hours<br> ;Timepoint(s) of evaluation of this end point: N/A