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: 2024年9月9日

适应症

试验速览

暂无简介。

•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

•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

发起方

Goethe University Frankfurt