EUCTR2011-000595-33-DE进行中（未招募）1 期
Randomized controlled trial to compare the effects of single versus repeated intracoronary application of autologous bone marrow-derived mononuclear cells on total and SHFM-predicted mortality in patients with chronic post-infarction heart failureREpetitive Progenitor cEll therapy in Advanced chronic hearT failure (REPEAT trial) - REPEAT
Goethe University Frankfurt0 个研究点目标入组 676 人开始时间: 2012年9月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 676
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
- •Previous myocardial infarction at least 3 months ago, open infarct vessel or bypass
- •Left ventricular ejection fraction (LVEF) = 45% on echocardiography
- •Stable chronic heart failure NYHA class II to III under constant (4 weeks) evidence-based optimal medical treatment
- •Age > 18 and expected to survive > 1 year
- •Written informed consent
- •Women of childbearing age: negative pregnancy test; effective contraception for the first 8 months in the trial
- •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 176
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •Non-ischemic cardiomyopathy
- •Foreseeable necessity for revascularization in other vessel than the infarct vessel at the time of study therapy
- •Hemodynamic relevant severe valvular disease with indication for operative / interventional revision
- •Heart failure with preserved ejection fraction (diastolic heart failure),
- •LVEF > 45%
- •Unstable Angina
- •Severe peripheral artery occlusive disease (= Fontaine stadium III)
- •Active infection (C-reactive protein > 10 mg/dl), any chronic inflammatory disease
- •Neoplastic disease without documented remission in the last 5 years
- •Stroke = 3 months
- •Impaired renal function (Serum creatinine > 2,5 mg/dl or eGRF (MDRD) =30l/ min) at the time of study inclusion
- •Relevant liver disease (GOT > 2x upper normal limit, spontaneous INR > 1,5).
- •Diseases of hematopoetic system, anemia (Hemoglobin < 8.5 g/dl), thrombocytopenia < 100.000/µl)
- •Splenomegaly
- •Allergy or intolerance of clopidogrel, prasugrel, ticagrelor, heparin, bivalirudin
- •History of bleeding disorder
- •Gastrointestinal bleeding = 3 months
- •Major surgery or trauma = 3 months
- •Uncontrolled hypertension
- •Pregnancy, lactation period
- •Mental retardation
- •Previous cardiac cell therapy within last 12 months
- •Participation in another clinical trial = 30 days
研究者
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