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
Hormone replacement therapy and cardiovascular disease: influence of oestrogen replacement therapy on chest pain
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
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