Congestive Heart Failure Clinical Trial
Official title:
A Single Centre, Randomised Controlled Study of the Effect of NOGA-guided Direct Intramyocardial Injection of Mesenchymal Stromal Cells on the Development of New Myocardium and Blood Vessels in Patients With Heart Failure
It is a single centre, randomised controlled study of the effect of NOGA-guided direct
intramyocardial injection of mesenchymal stromal cells on the development of new myocardium
and blood vessels in patients with heart failure.
Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before
injected into the myocardium.
The patients will be followed with safety, clinical, MRI and CT endpoints for 1 year.
The primary objective is to investigate the regenerative capacity of direct intra-myocardial
injection of mesenchymal stromal cells in patients with reduced left ventricular EF (≤45%)
and heart failure NYHA 2-3.
A total of 60 patients with will be enrolled in the study and randomised 2: 1 to cells or
placebo (saline).
The patients will be followed for 12 months. The primary endpoint is changes in left
ventricle end-systolic volume (LVESV) at 6 months follow-up.
The secondary endpoints are changes in left ventricular ejection fraction (LVEF),
end-diastolic volume and end-systolic mass at 6 months follow-up.
Other secondary endpoints are NYHA, CCS, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6
min walking test, and major adverse events endpoints: all-causes death, cardiovascular
death, and hospitalization for worsening heart failure and MI at 12 months follow-up.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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