NL-OMON47617招募中3 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 failure;REpetitive Progenitor cEll therapy in Advanced chronic hearT failure (REPEAT trial) - REPEAT
Goethe University Frankfurt0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Previous myocardial infarction at least 3 months ago, open infarct vessel or
- •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
排除标准
- •Non-ischemic cardiomyopathy
- •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) at the time of
- •study inclusion
- •Relevant liver disease (GOT > 2x upper normal limit, spontaneous INR >
- •Diseases of hematopoetic system, anemia (Hemoglobin < 8.5 mg/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
相似试验
进行中（未招募）
不适用
Repeated application of bone marrow-derived stem cells to treat chronicpost-infarction heart failureChronic post-infarction heart failure due to an at least 3 months old myocardial infarction, treated with optimal medication according to the evidence-based guidelines, in NYHA stadium II-IIIand with open vessel / bypass sullpying the previously infarcted areaEUCTR2011-000595-33-NLGoethe University Frankfurt676
进行中（未招募）
1 期
Repeated application of bone marrow-derived stem cells to treat chronic post-infarction heart failureChronic post-infarction heart failure due to an at least 3 months old myocardial infarction, treated with optimal medication according to the evidence-based guidelines, in NYHA stadium II-IIIand with open vessel / bypass sullpying the previously infarcted areaEUCTR2011-000595-33-DEGoethe University Frankfurt676
已完成
不适用
Randomised controlled trial to compare the effects of granulocyte-colony stimulating factor (G-CSF) and autologous bone marrow progenitor cells infusion on quality of life and left ventricular function in patients with heart failure secondary to ischaemic heart diseaseHeart failureISRCTN68837678Barts and the London NHS Trust (UK)300
进行中（未招募）
1 期
Randomised controlled trial comparing the effects of oxytocin 5 units IV bolus vs oxytocin 5 units IV infusion on cardiac output during caesarean section - Effect on cardiac output of oxytocin bolus vs. infusioEUCTR2007-002949-20-GBiverpool Women's NHS Foundation Trust32
进行中（未招募）
3 期
A clinical trial comparing daily versus intermittent vitamin D supplementation in children with nephrotic syndromeCTRI/2020/04/024598Jawaharlal Nehru medical college