A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary injection of progenitor cells compared to placebo injection in patients with Dilated Cardiomyopathy who have been pre-treated with G-CSF (Granocyte™) injections for 5 days, and patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to placebo injection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
10mcg/kg per day 5 days
intra coronary injection of stem cells or placebo
London Chest Hospital
London, United Kingdom
Change in left ventricular ejection fraction as measured by cardiac magnetic resonance imaging or computerised tomography
Time frame: 3 months
Change in: Concentrations of N-terminal prohormone of brain natriuretic peptide (cardiac enzyme)
Time frame: 3 months and 12 months
Changes in V02 max (exercise capacity)
Time frame: 3 months and 12 months
Changes in left ventricular ejection fraction, ventricular dimensions as measured by cardiac magnetic resonance imaging or computerised tomography
Time frame: 3 months and 12 months
Functional class changes according to NYHA and quality of life (QoL - EQ-5D & Kansas City) questionnaires
Time frame: 3 months and 12 months
Occurrence of a Major Adverse Cardiac Event (MACE) defined as cardiac death, myocardial infarction (CK / CK-MB over 2 times the upper limit of normal)
Time frame: 3 months and 12 months
Hospitalization for Heart failure & the occurrence of major arrhythmias defined as symptomatic ventricular tachycardia or survived sudden death
Time frame: 3 months and 12 months
The occurrence of major arrhythmias defined by symptomatic ventricular tachycardia or survived sudden death
Time frame: 3 months and 12 months
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