ISRCTN68837678
Completed
Not Applicable
Randomised controlled trial to compare the effects of granulocyte-colony stimulating factor (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
Barts and the London NHS Trust (UK)0 sites300 target enrollmentNovember 23, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Barts and the London NHS Trust (UK)
- Enrollment
- 300
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with a diagnosis of heart failure secondary to ischaemic heart disease attending a heart failure clinic for optimisation of their heart failure medication or who are on optimal heart failure treatment under supervision from their physician.
Exclusion Criteria
- •1\. Recent acute coronary sydrome as judged by a rise of troponin above normal values in the last 6 months
- •2\. The presence of cardiogenic shock
- •3\. The presence of acute left and/or right\-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
- •4\. Known severe pre\-existent left ventricular dysfunction (ejection fraction \<10% prior to randomisation)
- •5\. Congenital cardiac disease
- •6\. Cardiomyopathy secondary to a reversible cause e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity and chronic uncontrolled tachycardia
- •7\. Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
- •8\. Contra\-indication for bone marrow aspiration
- •9\. Known active infection
- •10\. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
Outcomes
Primary Outcomes
Not specified
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