EUCTR2013-002522-23-IT进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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
研究者
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