Contact information
Type
Scientific
Contact name
Dr Anthony Mathur
ORCID ID
Contact details
The London Chest Hospital
Bonner Road
London
E2 9JX
United Kingdom
+44 (0)208 983 2216
a.mathur@qmul.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
1.2
Study information
Scientific title
Acronym
REGENERATE-IHD
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
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Heart failure secondary to ischaemic heart disease.
Intervention
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
Intervention type
Other
Primary outcome measure
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 measures
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)
Overall study start date
18/05/2005
Overall study end date
18/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
300
Participant 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
Recruitment start date
18/05/2005
Recruitment end date
18/05/2010
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
The London Chest Hospital
London
E2 9JX
United Kingdom
Sponsor information
Organisation
Barts and the London NHS Trust (UK)
Sponsor details
The London Chest Hospital
Bonner Road
London
E2 9JX
England
United Kingdom
+44 (0)208 983 2213
qbird@btinternet.com
Sponsor type
Hospital/treatment centre
Website
http://www.heartcellsfoundation.com
ROR
Funders
Funder type
Charity
Funder name
The Heart Cells Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | interim results | 01/01/2009 | Yes | No |