Compare the Effects of Single Versus Repeated Intracoronary Application of Autologous Bone Marrow-derived Mononuclear Cells on Mortality in Patients With Chronic Post-infarction Heart Failure (REPEAT)

Johann Wolfgang Goethe University Hospital

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Heart Failure

Treatments: Biological: intracoronary infusion of autologous bone marrow-derived cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01693042

2011-000595-33 (EudraCT Number)

2011-01-01REPEAT

Details and patient eligibility

About

Single or repeated application of autologous bone marrow-derived stem cells to treat chronic post-infarction heart failure

Full description

Improve mortality and morbidity in patients with symptomatic chronic post-infarction heart failure under full dose conventional medical and device treatment including resynchronization therapy, by single versus repeated intracoronary infusion of autologous bone marrow-derived mononuclear cells.

Enrollment: 81 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• 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), chronic active hepatitis; any chronic inflammatory disease, HIV infection
• 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 > 1,5).
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Single intracoronary cell application

Active Comparator group

Description:

Single intracoronary application of autologous bone marrow derived mononuclear cells

Treatment:

Biological: intracoronary infusion of autologous bone marrow-derived cells

repeated (2 times) intracoronary cell application

Active Comparator group

Description:

2 times (interval 4 months) intracoronary application of autologous bone marrow derived mononuclear cells

Treatment:

Biological: intracoronary infusion of autologous bone marrow-derived cells