Clinical trial NCT01693042: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Keywords: heart failure
old myocardial infarction
bone marrow-derived mononuclear cells
chronic
ischemic
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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

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

Primary outcomes:
measure: Mortality at 2 years after inclusion into the study
timeFrame: 2 years
Secondary outcomes:
measure: Morbidity at 2 and 5 years after inclusion into the study
timeFrame: 2 years and 5 years
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Frankfurt
country: Germany
facility: Goethe University Frankfurt
city: Fulda
country: Germany
facility: Klinikum Fulda
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
city: Neustadt
country: Germany
facility: Krankenhaus Hetzelstift
city: Suhl
country: Germany
facility: Zentralklinikum Suhl
Study officials:
affiliation: Cardiology, Goethe University Frankfurt
name: Andreas M Zeiher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology, Goethe University Frankfurt
name: Birgit Assmus, MD
role: STUDY_DIRECTOR
References: