Heart failure revascularisation

ISRCTN	ISRCTN86284615
DOI	https://doi.org/10.1186/ISRCTN86284615
Protocol serial number	G9900791
Sponsor	Medical Research Council (MRC) (UK)
Funder	Initial funding provided by the Medical Research Council (UK).

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof John GF Cleland
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Heart failure with left ventricular systolic dysfunction
Intervention	Best medical therapy versus best medical therapy and revascularisation
Intervention type	Other
Primary outcome measure(s)	All-cause mortality
Key secondary outcome measure(s)	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)
Completion date	30/09/2011

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	800
Key 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
Key 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
Date of first enrolment	01/01/2002
Date of final enrolment	30/09/2011

Academic Unit of Cardiology

Kingston-upon-Hull
HU16 5TX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011		Yes	No
Protocol article	protocol	01/06/2003		Yes	No