A double blinded, placebo controlled, pilot study to investigate the safety, tolerability, pharmacokinetics and acute cardiovascular responses of a 7 day oral treatment with the investigational drug BAY 1067197 in patients with chronic heart failure

Phase 1

• Conditions: Chronic systolic heart failure; MedDRA version: 16.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002522-23-NL
• Lead Sponsor: Bayer Healthcare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-04
• Study Completion: 2015-04-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

- Clinical diagnosis of chronic systolic heart failureof ischemic or non-ischemic etiology: NYHA class I-IIIand treatment with standard pharmacological therapy for the treatment of systolic heart failure including ß-blocker = 4 weeks prior to randomization
- Left ventricular ejection fraction = 40%: by any imaging technique within the last 3 months will be accepted for screening purposes but will be verified by baseline CMR
- Sinus rhythm for at least 4 weeks prior to randomization
- No planned changes to heart failure related drug therapy for the
duration of study drug treatment
- Substantial dysfunctional but viable myocardium as demonstrated by the baseline CMR:Based on a standard 17-segment model (AHA), 3 or more segments require demonstration of dysfunction (defined by visible assessment of the performing investigator) and viability (defined as < 25% of segment area with scar burden – in patients with CAD or no (i.e. zero) scar burden in patients without CAD [idiopathic CM patient])
- Age: 18 to 75years (inclusive) at the first screening visit
- Body mass index (BMI): above/equal 18.0 and below/equal 34.9 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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Atrial fibrillation / atrial flutter within the last 4 weeks prior to randomization or currently persistent/permanent atrial fibrillation / atrial flutter
- Primary valvular disease (severe valvular disease) with planned valve repair or replacement
- Non-idiopathic non-ischemic causes for cardiomyopathy (constrictive, restrictive, or hypertrophic cardiomyopathy; acute myocarditis)
- Listing for heart transplantation and/or anticipated/implanted ventricular assist device
- Clinically relevant ventricular arrhythmias within the last 2 months (sustained ventricular tachycardia, ventricular flutter or fibrillation), based on either medical history or ICD-testing results (if applicable)
- Unstable cardiac condition, indicated by requirement of IV drug (diuretic, inotrope, etc.) or NYHA IV within 4 weeks prior to randomization
- Coronary revascularization within 4 weeksprior to randomization or if revascularization is anticipated or needed
- Current permanent or intermittentAV-Block > I°or history of AV-Block > I°within six months before enrollment
- PR duration = 300 ms
- Acute Coronary Syndrome (defined as unstable angina [UA], non-ST elevation myocardial infarction [NSTEMI], ST elevation myocardial infarction [STEMI]) within 2 months prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified