Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
05/06/2014
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 J McLenachan

ORCID ID

Contact details

Leeds General Infirmary
Department of Cardiology
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 2926476
Jim.McLenachan@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VCO500 J458 448505

Study information

Scientific title

Acronym

Study hypothesis

Angina in post-menopausal women is a common clinical problem that is often under-investigated and under-treated. While most women with angina have atherosclerotic coronary disease, many have angina with anatomically normal coronary arteries (so-called Syndrome X). Those women with angina and coronary artery disease have a high risk of major cardiovascular events including unstable angina, myocardial infarction and death. Indeed, recent evidence suggests that while coronary disease is declining in men, the incidence of major events continues to rise in women, and may equal that of men in less than two decades. Women with angiographically normal coronary arteries present a different problem; although they have a good prognosis, their symptoms do not respond well to conventional anti-angina therapy and their morbidity and hospital re-admission rate is high. Hormone replacement therapy (HRT) with oestrogen reduces the incidence of cardiac events in post-menopausal women by up to 50%, by mechanisms that have not been elucidated. Interest has recently focused on the functions of the innermost layer of the coronary artery, the coronary endothelium. In health, the endothelial cells cause the artery to dilate in response to a number of physical and chemical stimuli. This function, called endothelium-dependant vasodilation, is lost in the early phase of coronary atherosclerosis and may precipitate further vascular damage. In animal models, HRT given to oophorectomised females can restore normal endothelial function, and may retard the development of atherosclerosis. An analagous abnormality in the endothelial control of coronary blood flow has been identified in Syndrome X. In neither case has the effect of HRT on coronary artery responsiveness been studied in humans. Nor has there been investigation of the effect of HRT on symptoms (i.e. chest pain, exercise tolerance) in either women with or without coronary disease. We plan to assess the influence of HRT on coronary artery responses in post-menopausal women with angina, both with and without coronary artery disease, in an unblinded single angiographic study. Ischaemic heart disease accounts for 24% of all deaths in women aged between 55-74, being the largest single cause of death in this group. The potential benefit to the nation, in both health and financial terms, of more effective therapy and prevention of this burden of disease is great. This study aims to examine mechanisms by which HRT might prevent death and other major cardiovascular events, as well as exploring for the first time the therapeutic potential of HRT in the treatment of chest pain in with and without coronary artery disease. The information acquired may provide the basis for larger controlled trials of HRT as symptomatic and preventative therapy for heart disease in post-menopausal women.

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

Not Specified

Patient information sheet

Condition

Cardiovascular diseases: heart disease

Intervention

Not provided at time of registration

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/01/1994

Overall trial end date

30/09/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Post-menopausal women with angina

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

08/01/1994

Recruitment end date

30/09/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

Publication citations

Additional files

Editorial Notes