Condition category
Circulatory System
Date applied
18/10/2000
Date assigned
18/10/2000
Last edited
16/05/2011
Prospective/Retrospective
Prospectively 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

Professor John GF Cleland

ORCID ID

Contact details

Academic Unit of Cardiology
University of Hull
Castle Hill Hospital
Cottingham
Kingston-upon-Hull
HU16 5TX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9900791

Study information

Scientific title

Acronym

Study hypothesis

To determine whether coronary revascularisation, improves the survival of patients with heart failure due to coronary disease who have evidence of dysfunctional but viable myocardium or stress-induced ischaemia (but who do not require revascularisation for the relief of angina) and who are receiving optimal medical treatment.

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 with left ventricular systolic dysfunction

Intervention

Best medical therapy versus best medical therapy and revascularisation

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

All-cause mortality

Secondary outcome measures

1. All-cause mortality or myocardial infarction more than 72 hours from coronary revascularisation
2. All-cause mortality and all-cause hospitalisation
3. All-cause mortality and unplanned cardiovascular hospitalisation
4. Days alive and out of hospital
5. Death, non-fatal myocardial infarction or non-fatal stroke
6. Symptom scores for angina and heart failure
7. Quality of life (using EuroHeart Failure, EQ-5D and Minnesota Living with Heart Failure Questionnaires)
8. Mean cost of Therapy (a health economic outcome)

Overall trial start date

01/01/2002

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Heart failure (in the investigators' opinion) with left ventricular systolic dysfunction (ejection fraction less than 35%) requiring chronic diuretic therapy
2. Coronary disease as the cause of heart failure as evidenced by a history of previous myocardial infarction, previous revascularisation or previous angiography
3. Stress-induced myocardial ischaemia or evidence of myocardial hibernation/stunning affecting five or more left ventricular segments in a 16-segment model. The core laboratories will make the decision about whether the test identifies a sufficient volume of affected myocardium

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

800

Participant exclusion criteria

1. Patients who are not candidates for Coronary Artery Bypass Graft (CABG) because of frailty or serious co-morbidity (eg:- severe lung disease, metastatic carcinoma)
2. Unstable angina, myocardial infarction or stroke within the preceding two months
3. Inability to give written informed consent
4. Unwilling to consent to being contacted directly by staff at the data centre or unwilling to allow their hospital notes to be copied and sent to the data centre
5. Patients being considered for revascularisation for the relief of chest pain (angina) or valve surgery
6. Patients involved in another randomised controlled trial

Recruitment start date

01/01/2002

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Unit of Cardiology
Kingston-upon-Hull
HU16 5TX
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Initial funding provided by the Medical Research Council (UK).

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

1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/12798827
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21156659

Publication citations

  1. Protocol

    Cleland JG, Freemantle N, Ball SG, Bonser RS, Camici P, Chattopadhyay S, Dutka D, Eastaugh J, Hampton J, Large S, Norell MS, Pennell DJ, Pepper J, Sanda S, Senior R, Smith D, The heart failure revascularisation trial (HEART): rationale, design and methodology., Eur. J. Heart Fail., 2003, 5, 3, 295-303.

  2. Results

    Cleland JG, Calvert M, Freemantle N, Arrow Y, Ball SG, Bonser RS, Chattopadhyay S, Norell MS, Pennell DJ, Senior R, The Heart Failure Revascularisation Trial (HEART)., Eur. J. Heart Fail., 2011, 13, 2, 227-233, doi: 10.1093/eurjhf/hfq230.

Additional files

Editorial Notes