Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00239590
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2005-10-13
Brief Title:
Testosterone and Myocardial Perfusion in Coronary Heart Disease CHD
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Effects of Chronic Testosterone on Myocardial Ischaemia and Endothelial Function in Men With Documented Coronary Heart Disease
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Testosterone has traditionally been regarded as a risk factor for heart disease due to the fact that males have a higher incidence of this disease than women at least until the menopause However recent studies have shown that men with low levels of testosterone may be at an increased risk of developing coronary heart disease furring up of the blood vessels supplying blood to the heart Our group has demonstrated a relaxing effect of testosterone in isolated animal coronary arteries blood vessels supplying blood to the heart We have shown that short-term testosterone administration can increase coronary artery and brachial artery blood vessel in the arm blood flow and can decrease the lack of blood supply to the heart muscle in men with coronary artery disease These findings indicate a need for similar but longer-term studies to investigate the possible beneficial effects of longer-term testosterone therapy on the heart and blood vessels Should this treatment be shown to be beneficial to men with coronary artery disease it may be a useful additional therapy for men with the furring up of arteries in the heart and the resulting angina
Aim To investigate our hypothesis that testosterone can beneficially affect myocardial perfusion vascular reactivity metabolic risk factors for coronary heart disease and improve quality of life in men with low plasma testosterone levels and coronary heart disease
Aim To investigate our hypothesis that testosterone can beneficially affect myocardial perfusion vascular reactivity metabolic risk factors for coronary heart disease and improve quality of life in men with low plasma testosterone levels and coronary heart disease
Detailed Description:
The main purpose of this project is to determine whether testosterone treatment over a number of weeks can beneficially affect myocardial perfusion vascular reactivity metabolic risk factors and quality of life in men with documented coronary heart disease Men with documented significant coronary artery disease and a positive exercise test for myocardial ischaemia will be enrolled into the study They will be randomised to active testosterone therapy 5 mgday or placebo for 2 months After 2 months they will undergo MRI perfusion scanning radial artery applanation tonometry to assess endothelial function blood sampling for analysis of metabolic risk factors for coronary heart disease complete quality of life questionnaires and will cross-over to the opposite treatment After a further 2 month period these tests will be repeated Angina diaries will be kept for the duration of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None