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22 May 2012
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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN68837678 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | REGENERATE-IHD |
| Serial number at source | 1.2 |
| Study hypothesis |
1. Administration of G-CSF to patients with heart failure secondary to ischaemic heart disease will lead to an increase in circulating progenitor cells as measured by peripheral CD34+ positive cell counts
2. Cardiac function and symptoms will improve in patients in whom the peripheral CD34+ counts increase in response to G-CSF administration 3. Direct coronary injection of autologous bone marrow derived stem cells will confer an additional improvement in cardiac function and symptoms above that derived from G-CSF infusion alone 4. Direct intramyocardial injection of autologous bone marrow derived stem cells will lead to an improvement in cardiac function and symptoms above that derived from G-CSF infusion alone |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Heart failure secondary to ischaemic heart disease. |
| Participants - 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. |
| Participants - 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 |
| Anticipated start date | 18/05/2005 |
| Anticipated end date | 18/05/2010 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 300 |
| Interventions | Daily subcutaneous injections of G-CSF at 10 µg/kg or placebo OR daily subcutaneous injections of G-CSF at 10 µg/kg followed by intracoronary injection of stem cells or placebo OR daily subcutaneous injections of G-CSF at 10 µg/kg followed by intramyocardial injection of stem cells or placebo |
| Primary outcome measure(s) |
At 6 months:
1. The change in global left ventricular ejection fraction (LVEF) at 6 months relative to baseline measured by quantitative left ventriculography 2. The change in regional wall motion score index at 6 months relative to baseline measured by tissue doppler imaging 3. The change in quality of life scores compared to baseline |
| Secondary outcome measure(s) |
At 6 months:
1. Death as result of the underlying cardiac condition 2. The occurence of major arrhythmias defined as ventricular tachycardia or survived sudden death 3. Presence of clinically evident heart failure 4. The change in global left ventricular ejection fraction at 6 months relative to baseline measured by resting echocardiography 4. The change in global and regional wall motion score index measured by resting echocardiography 5. Serum levels of amino-terminal pro-brain natriuretic peptide (NT-BNP) 6. Change in myocardial function as measured by magnetic resonance imaging (MRI) scanning (first 40 suitable patients in each group) 7. Change in voltage and shortening maps as assessed by NOGA (intramyocardial group only) At 12 months: 1. The occurrence of a major adverse cardiac event (MACE) 2. The change in left ventricular ejection fraction relative to baseline measured by resting echocardiography using Simpson's rule 3. The change in global and regional wall motion score index measured by resting echocardiography and tissue doppler imaging 4. Change in quality of life scores 5. Serum levels of amino-terminal pro-brain natriuretic peptide (NT-BNP) 5. Change in myocardial function as measured by MRI scanning (first 40 suitable patients in each group) |
| Sources of funding | The Heart Cells Foundation |
| Trial website | |
| Publications | |
| Contact name | Dr Anthony Mathur |
| Address |
The London Chest Hospital
Bonner Road |
| City/town | London |
| Zip/Postcode | E2 9JX |
| Country | United Kingdom |
| Tel | +44 (0)208 983 2216 |
| Fax | +44 (0)208 983 2381 |
| a.mathur@qmul.ac.uk | |
| Sponsor | Barts and the London NHS Trust (UK) |
| Address |
The London Chest Hospital
Bonner Road |
| City/town | London |
| Zip/Postcode | E2 9JX |
| Country | United Kingdom |
| Tel | +44 (0)208 983 2213 |
| Fax | +44 (0)208 983 2262 |
| qbird@btinternet.com | |
| Sponsor website: | http://www.heartcellsfoundation.com |
| Date applied | 28/07/2005 |
| Last edited | 04/07/2007 |
| Date ISRCTN assigned | 23/11/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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