Combined CABG and Stem-Cell Transplantation for Heart Failure
Sponsor:
Helsinki University
Location:
Department of Cardiothoracic Surgery, Meilahti Hospital
Country:
Finland 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 scheduled to coronary bypass operation.
Eligible Ages for Trial:
18 - 75
Eligible Genders for Trial:
Both
Illness:
Heart Disease Inclusion Criteria:
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 Criteria:
- 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
October 1, 2006 - December 1, 2010
Trial Status:
Recruiting Contact:
Ari Harjula, MD,PhD, +3585064814, ari.harjula@hus.fi
Print
Email page