EUCTR2011-000595-33-NL
Active, not recruiting
Not Applicable
Randomized controlled trial to compare the effects of single versusrepeated intracoronary application of autologous bone marrow-derivedmononuclear cells on total and SHFM-predicted mortality in patients withchronic post-infarction heart failureREpetitive Progenitor cEll therapy in Advanced chronic hearT failure(REPEAT trial) - REPEAT
Goethe University Frankfurt0 sites676 target enrollmentNovember 19, 2015
ConditionsChronic 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 areaTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic 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-III
- Sponsor
- Goethe University Frankfurt
- Enrollment
- 676
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 – 80 years
- •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
Exclusion Criteria
- •Non\-ischemic cardiomyopathy
- •Necessity for revascularization in other vessel than the infarct vessel
- •at the time of study therapy
- •XML File Identifier: v\+I18a18i5BGdxhV1XCe9gTJXBA\=
- •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)
Outcomes
Primary Outcomes
Not specified
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