Condition category
Circulatory System
Date applied
30/07/2010
Date assigned
30/07/2010
Last edited
12/09/2016
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

Mr Mike Lammiman

ORCID ID

Contact details

Department of Cardiology
Castle Road
Cottingham
HU16 5JQ
United Kingdom
-
Mike.Lammiman@hey.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2995

Study information

Scientific title

Heart Revascularisation Trial - UK

Acronym

Heart Revascularisation Trial - UK

Study hypothesis

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

MREC, ref: 0/3/35

Study design

Multicentre randomised interventional process of care and treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

Primary outcome measures

Survival

Secondary outcome measures

Determine whether coronary revascularisation reduces all-cause and cause-specific hospitalisation

Overall trial start date

07/03/2003

Overall trial end date

20/11/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 140; UK sample size: 140

Participant 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

Recruitment start date

07/03/2003

Recruitment end date

20/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hull and East Yorkshire Hospitals NHS Trust
Cottingham
HU16 5JQ
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospitals NHS Trust (UK)

Sponsor details

Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.hey.nhs.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Arthritis Research UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes

12/09/2016: No publications found, verifying study status with principal investigator.