Heart Revascularisation Trial - UK

ISRCTN	ISRCTN66339600
DOI	https://doi.org/10.1186/ISRCTN66339600
Secondary identifying numbers	2995

Submission date: 30/07/2010
Registration date: 30/07/2010
Last edited: 13/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Mike Lammiman
Scientific

Department of Cardiology
Castle Road
Cottingham
HU16 5JQ
United Kingdom

Email	Mike.Lammiman@hey.nhs.uk

Study information

Study design	Multicentre randomised interventional process of care and treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Heart Revascularisation Trial - UK
Study acronym	Heart Revascularisation Trial - UK
Study objectives	Patients with heart failure, left ventricular systolic dysfunction and definite coronary disease in whom angina is not the predominant symptom will be identified. Cardiac nuclear techniques or stress echocardiography will then be used to identify patients with substantial stress-induced ischaemia or myocardial hibernation/stunning. Patients with either of these problems will be randomised to best medical treatment alone versus best medical therapy and angiography with the intention of, where possible, revascularisation. Revascularisation may be by whichever conventional means the attending cardiologist and cardiac surgeon agree is advisable. Patients will be followed until 90% of patients in the worst performing group have died to determine the effect of the above interventions on all-cause mortality, symptoms, quality of life and recurrent hospitalisation.
Ethics approval(s)	MREC, ref: 0/3/35
Health condition(s) or problem(s) studied	Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
Intervention	1. Optimal medication plus angiography with, if appropriate, CABG 2. Optimal medication Follow-up length: 60 months Study entry: single randomisation only
Intervention type	Mixed
Primary outcome measure	Survival
Secondary outcome measures	Determine whether coronary revascularisation reduces all-cause and cause-specific hospitalisation
Overall study start date	07/03/2003
Completion date	20/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 140; UK sample size: 140
Total final enrolment	138
Key inclusion criteria	1. Heart failure (in the investigators opinion) 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. Left ventricular systolic dysfunction (ejection fraction less than 35%) 4. Stress-induced myocardial ischaemia or evidence of myocardial hibernation/stunning affecting five or more left ventricular segments in a 16-segment model 5. Male and female, lower age limit of 18 years
Key exclusion criteria	1. Inability to give written informed consent. No age limits are stipulated but patients will have to be over 18 years to give consent and some patients may be considered too frail to survive surgery and would be excluded. 2. Patients who are not candidates for coronary artery bypass graft (CABG) surgery because of frailty or serious co-morbidity, e.g., severe lung disease, metastatic carcinoma. N.B. Some patients will be candidates for percutaneous transluminal coronary angioplasty (PTCA) but prior to randomisation (i.e. prior to doing an angiogram for study purposes) the investigator should be willing to send the patient to CABG surgery in case that is the preferred mode of revascularisation. 3. Unstable angina, myocardial infarction or stroke within the preceding 2 months 4. Patients being considered for revascularisation for the relief of chest pain (angina) or for valve surgery
Date of first enrolment	07/03/2003
Date of final enrolment	20/11/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Hull and East Yorkshire Hospitals NHS Trust

Cottingham
HU16 5JQ
United Kingdom

Sponsor information

Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre

Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
England
United Kingdom

Website	http://www.hey.nhs.uk/
"ROR"	https://ror.org/01b11x021

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Arthritis Research UK
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011	13/06/2019	Yes	No

Editorial Notes

13/06/2019: Publication reference and total final enrolment number added.
12/09/2016: No publications found, verifying study status with principal investigator.