A double blinded, placebo controlled, study to investigate the safety, tolerability, pharmacokinetics and acute cardiovascular responses of a 7 day oral treatment with the partial adenosine A1 receptor agonist BAY 1067197 in patients with chronic systolic heart failure : PARSiFAL-pilot study. - the PARSiFAL-pilot study

Bayer Healthcare AG0 个研究点目标入组 36 人开始时间: 2014年2月4日最近更新: 2019年11月25日

试验速览

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•- 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

•- 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

发起方