EUCTR2005-002706-27-GB
Active, not recruiting
Not Applicable
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
Barts and the London NHS Trust, Department of Cardiology0 sites300 target enrollmentJune 15, 2005
DrugsGRANOCYTE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart failure secondary to ischaemic heart disease
- Sponsor
- Barts and the London NHS Trust, Department of Cardiology
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 10 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 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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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