Randomised Control Trial To Compare The Effects Of G-CSF And Autologous Bone Marrow Progenitor Cells Infusion On Quality Of Life And Left Ventricular Function In Patients With Heart Failure Secondary to Ischaemic Heart Disease
- Conditions
- Heart failure secondary to ischaemic heart disease
- Registration Number
- EUCTR2005-002706-27-GB
- Lead Sponsor
- Barts and the London NHS Trust, Department of Cardiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Patients with a diagnosis of heart failure secondary to ischaemic heart disease attending the 'Heart Failure clinic' for optimisation of their heart failure medication or who are on optimal heart failure treatment under supervision from their physician
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Recent acute coronary syndrome as judged by a rise of Troponin above normal values in the last 6 months
The presence of cardiogenic shock
The presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
Known severe pre-existent left ventricular dysfunction (ejection fraction < 10% prior to randomisation)
Congenital cardiac disease
Cardiomyopathy 2o to a reversible cause e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity & chronic uncontrolled tachycardia
Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
Contra-indication for bone marrow aspiration
Known active infection
Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
Lifestyle with high risk for infection with HIV, HBV or HCV
Chronic inflammatory disease
Serious known concomitant disease with a life expectancy of less than one year
Follow-up impossible (no fixed abode, etc)
Previous participation in this study
Female subjects of childbearing potential
Patients with a ventricular pacemaker who are in a paced rhythm for >80% of the time
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess whether peripheral mobilisation of autologous stem cells and intracardiac administration of the mononuclear fraction of bone marrow derived cells will lead to an improvement in symptoms and cardaic function in patients with heart failure;Secondary Objective: To assess the cost implications of such a procedure.;Primary end point(s): The change in global left ventricular ejection fraction (LVEF) at 6 months relative to baseline measured by quantitative left ventriculography (QLV). The change in regional wall motion score index at 6 months relative to baseline measured by tissue doppler imaging. The change in quality of life scores compared to baseline. <br><br><br><br>
- Secondary Outcome Measures
Name Time Method