Chronic systolic heart failure MedDRA version: 16.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849
Conditions
Interventions
Product Name: Bay 1067197 HLC 10 mg tablet
Product Code: Bay 1067197 10 mg tablet
Pharmaceutical Form: Tablet
Current Sponsor code: BAY 86-8901 (hydrochloride of BAY 1067197)
Other descriptive name: B
Sponsors
Bayer Healthcare AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate the safety and tolerability of a multiple dose 7 day once-daily treatment of BAY 1067197 versus a 7 day treatment of placebo in patients with chronic systolic heart failure, determined by the incidence and severity of adverse clinical events, new laboratory and electrocardiographic abnormalities and to investigate the pharmacokinetics of a 7 day treatment with BAY 1067197 in patients with chronic systolic heart failure;Secondary Objective: The secondary objectives of this study are to -explore the effects of BAY 1067197 on left ventricular function compared to baseline and placebo as determined by change in left ventricular ejection fraction and other parameters related to cardiac function - explore the effects of BAY 1067197 on diastolic function - explore the effects of BAY 1067197 on vasoactive hormones and further biomarkers - explore the effects of BAY 1067197 on markers of renal function - asses the pharmacokinetic profile of BAY 1067197 - investigate the hemodynamic effects of 7 d treatment;Primary end point(s): 1- Incidence and severity of adverse events with specific regard to changes in heart rate, blood pressure and the incidence of higher degree AV-blocks > I° 2- Left ventricular ejection fraction at rest, measured by cardiac magnetic resonance tomography (CMR) ;Timepoint(s) of evaluation of this end point: 1- Treatment phase up to 21 days after dosing (Up to day 28) 2- At end of treatment phase (day 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacodynamic and Pharmacokinetic;Timepoint(s) of evaluation of this end point: Treatment phase up to 21 days after dosing | — |
Countries
Germany, Italy, Netherlands
Contacts
Public ContactBayer Clinical Trials Contact
Bayer Healthcare AG
Outcome results
None listed