Status:
UNKNOWN
Combined CABG and Stem-Cell Transplantation for Heart Failure
Lead Sponsor:
University of Helsinki
Conditions:
Heart Failure
Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a prospective double blind trial of intraoperative transmyocardial bone marrow-derived mesenchymal cell transplantation vs placebo in patients with low left ventricular ejection fraction sched...
Detailed Description
The prevalence of symptomatic heart failure in general population is up to 2% and the prevalence increases rapidly with age. Half of the patients with symptomatic heart failure will die within 4 years...
Eligibility Criteria
Inclusion
- General (patients must have all)
- Symptomatic heart failure.
- Scheduled to CABG
- Be 18 to 75 years of age
- Informed Consent obtained
- Heart Failure Presentation
- Patients of either gender, who has evaluated in cardiovascular laboratory and scheduled to CABG with moderate heart failure, will be eligible
- NYHA II-IV symptoms
- Left ventricular ejection fraction in screening echocardiography 15 to 45%.
- Optimal heart failure medication and coronary medication before operation, containing at least two heart failure drugs: must have ACE-inhibitor, or AT II blocker, and/or b-blocker together with diuretics, digitalis or aldosterone antagonist, and coronary medication: a statin and anticoagulation, either aspirin or clopidogrel.
Exclusion
- Heart failure due to left ventricular outflow track obstruction (valve problem or HOCM)
- History of life-threatening ventricular arrhythmias or resuscitation, condition which may be repeatable or implanted ICD.
- Stroke or other disabling condition with in 3 months before screening
- Contraindications to coronary angiogram or MRI
- Other serious disease limiting life expectancy
- Participation in an other clinical trial
- Severe valve disease: mitral, aortic, tricuspid or pulmonic stenosis / insufficiency
- Scheduled valve operation
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00418418
Start Date
October 1 2006
End Date
December 1 2010
Last Update
August 19 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Cardiothoracic Surgery, Meilahti Hospital
Helsinki, Finland, 00029-HUS