Multiple Dose Study in Heart Failure of BAY 1067197
Multiple Dose Study in Heart Failure of BAY 1067197
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.
-  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)