Condition category
Circulatory System
Date applied
28/07/2005
Date assigned
23/11/2005
Last edited
04/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

18/05/2005

Overall trial end date

18/05/2010

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom
+44 (0)208 983 2213
qbird@btinternet.com

Sponsor type

Government

Website

http://www.heartcellsfoundation.com

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 interim results in http://www.ncbi.nlm.nih.gov/pubmed/19105621

Publication citations

  1. Interim results

    Yeo C, Mathur A, Autologous bone marrow-derived stem cells for ischemic heart failure: REGENERATE-IHD trial., Regen Med, 2009, 4, 1, 119-127, doi: 10.2217/17460751.4.1.119.

Additional files

Editorial Notes