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

Completed

• Conditions: Heart failure secondary to ischaemic heart disease.; Circulatory System; Heart failure

• Registration Number: ISRCTN68837678
• Lead Sponsor: Barts and the London NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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)
11. Lifestyle with high risk for infection with HIV, HBV, or HCV
12. Chronic inflammatory disease
13. Serious known concomitant disease with a life expectancy of less than one year
14. Follow-up impossible (no fixed abode etc.)
15. Previous participation in this study
16. Female subjects of childbearing potential
17. Paced rhythm >80% of the time
18. Serum creatinine >200 mg/dl

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At 6 months:<br>1. The change in global left ventricular ejection fraction (LVEF) at 6 months relative to baseline measured by quantitative left ventriculography<br>2. The change in regional wall motion score index at 6 months relative to baseline measured by tissue doppler imaging<br>3. The change in quality of life scores compared to baseline