Multiple Dose Study in Heart Failure of BAY 1067197

NCT ID: NCT02040233

Last Updated: 2019-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-28
• Study Completion Date: 2015-04-02

Brief Summary

This is a study to investigate the safety, tolerability and early effects on cardiac function of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied once daily over 7 days in addition to standard therapy including a beta-blocker. The aim of the study is to assess if a 7 day treatment with BAY1067197 is well tolerated when given on top of standard therapy for heart failure. Furthermore, the study aims to assess if cardiac function improves in the early course of therapy.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BAY1067197 (10 mg)

Group Type: ACTIVE_COMPARATOR

BAY1067197 (10 mg)

Intervention Type: DRUG

10 mg BAY1067197 for 7 d treatment once daily as oral application

BAY1067197

Group Type: ACTIVE_COMPARATOR

BAY1067197

Intervention Type: DRUG

The dose escalation to the second dose step will proceed only if the previous dose step has shown acceptable safety and tolerability 5 mg / or 10 mg / or 20 mg BAY1067197 for 7 d treatment as oral application.

Placebo (10 mg)

Group Type: PLACEBO_COMPARATOR

Placebo (10 mg)

Intervention Type: DRUG

10 mg Placebo for 7 d treatment once daily as oral application

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

5 mg / or 10 mg / or 20 mg Placebo for 7 d treatment once daily as oral application

Interventions

BAY1067197 (10 mg)

10 mg BAY1067197 for 7 d treatment once daily as oral application

Intervention Type: DRUG

BAY1067197

The dose escalation to the second dose step will proceed only if the previous dose step has shown acceptable safety and tolerability 5 mg / or 10 mg / or 20 mg BAY1067197 for 7 d treatment as oral application.

Intervention Type: DRUG

Placebo (10 mg)

10 mg Placebo for 7 d treatment once daily as oral application

Intervention Type: DRUG

Placebo

5 mg / or 10 mg / or 20 mg Placebo for 7 d treatment once daily as oral application

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of chronic systolic heart failure of ischemic or non-ischemic etiology:(New York Heart Association)NYHA class I-III and treatment with standard pharmacological therapy for the treatment of systolic heart failure including β-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(Cardiac Magnetic Resonance Tomography)
• 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 - American Heart Association), 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 (Coronary Artery Disease) or no (i.e. zero) scar burden in patients without CAD [idiopathic CM patient])
• Men or confirmed postmenopausal women or women without childbearing potential.
• Age: 18 to 75 years (inclusive) at the first screening visit.
• Body Mass Index (BMI) :above /equal 18.0 and below/equal 34.9kg/m²

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 weeks prior to randomization or if revascularization is anticipated or needed
• Current permanent or intermittent AV-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
• Subjects with untreated hyperthyroidism or hypothyroidism and non-stable thyroid function (intake of stable thyroid hormone substitution allowed)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Berlin, , Germany

Bergamo, Lombardy, Italy

Brescia, Lombardy, Italy

Milan, Lombardy, Italy

Groningen, , Netherlands

Wroclaw, , Poland

Countries

Germany; Italy; Netherlands; Poland

Related Links

http://www.clinicaltrialsregister.eu

Click here and search for information provided by the EMA

https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products.

Other Identifiers

2013-002522-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16782

Identifier Type: -

Identifier Source: org_study_id