Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131183
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2005-08-15
Brief Title:
Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
The Effect of Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina
Status:
COMPLETED
Status Verified Date:
2006-09
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:
This study aims to address the following questions on the effects of testosterone therapy in men with coronary ischaemia
Does the anti-anginal effect persist long term Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months The investigators earlier studies were limited to 3 months
Does testosterone therapy in men affect the levels of measurable atheroma There is currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of atheroma although there is abundant evidence in animals to suggest a potential improvement
This study addresses the two issues and would be of one-year duration but would be the longest trial of testosterone therapy in men with cardiovascular disease The primary endpoint is the change in time to ST- segment depression of 1mm during exercise testing
Does the anti-anginal effect persist long term Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months The investigators earlier studies were limited to 3 months
Does testosterone therapy in men affect the levels of measurable atheroma There is currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of atheroma although there is abundant evidence in animals to suggest a potential improvement
This study addresses the two issues and would be of one-year duration but would be the longest trial of testosterone therapy in men with cardiovascular disease The primary endpoint is the change in time to ST- segment depression of 1mm during exercise testing
Detailed Description:
In the past 4 years the investigators research group has completed 2 studies on the effect of testosterone therapy on exercise induced coronary ischaemia clinically manifest as angina pectoris We the investigators at Sheffield Teaching Hospitals have shown that testosterone replacement therapy improved exercise duration on the treadmill and prolonged time to ischaemia ischaemic threshold Moreover we demonstrated a dose response relationship between the increase in exercise duration and the baseline testosterone level so that men with lower baseline testosterone level derived the greatest symptomatic benefit from replacement therapy Importantly we have also demonstrated that the effects of testosterone are maintained in the presence of concomitant anti-anginal drug therapy and at physiological levels of testosterone therapy English et al 2000 Malkin 2004
Furthermore we have found the prevalence of men with coronary disease and low serum testosterone levels to be approximately 25 This represents a large population of men with low testosterone levels that may benefit symptomatically from testosterone therapy These men qualify for androgen replacement therapy per se simply to relieve hypogonadal symptoms and maintain bone mineral density and there are clinical guidelines recommending physiological testosterone replacement in this cohort Morales and Lunenfeld 2002 The safety issues relating to testosterone treatment which comprise a theoretical increased risk of prostate neoplasia and increased erythropoiesis are of limited relevance in this population because replacement therapy only returns the testosterone level to the physiological range Indeed there is no evidence that appropriate testosterone therapy increases the risk of prostate cancer More importantly prostate cancer can be identified early by screening for prostate specific antigen allowing careful surveillance during replacement therapy
This study aims to address the following questions on the effects of testosterone therapy in men with coronary ischaemia
Does the anti-anginal effect persist long term Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months Our earlier studies were limited to 3 months
Does testosterone therapy in men affect the levels of measurable atheroma There is currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of atheroma although there is abundant evidence in animals to suggest a potential improvement
This study addresses the two issues and would be of one-year duration but would be the longest trial of testosterone therapy in men with cardiovascular disease
The primary endpoint is change in time to ST- segment depression of 1mm during exercise testing
Furthermore we have found the prevalence of men with coronary disease and low serum testosterone levels to be approximately 25 This represents a large population of men with low testosterone levels that may benefit symptomatically from testosterone therapy These men qualify for androgen replacement therapy per se simply to relieve hypogonadal symptoms and maintain bone mineral density and there are clinical guidelines recommending physiological testosterone replacement in this cohort Morales and Lunenfeld 2002 The safety issues relating to testosterone treatment which comprise a theoretical increased risk of prostate neoplasia and increased erythropoiesis are of limited relevance in this population because replacement therapy only returns the testosterone level to the physiological range Indeed there is no evidence that appropriate testosterone therapy increases the risk of prostate cancer More importantly prostate cancer can be identified early by screening for prostate specific antigen allowing careful surveillance during replacement therapy
This study aims to address the following questions on the effects of testosterone therapy in men with coronary ischaemia
Does the anti-anginal effect persist long term Many of the published studies are acute single dose trials and none of the chronic studies have assessed patients formally beyond a few months Our earlier studies were limited to 3 months
Does testosterone therapy in men affect the levels of measurable atheroma There is currently no in-vivo human evidence that androgen therapy inhibits or reduces levels of atheroma although there is abundant evidence in animals to suggest a potential improvement
This study addresses the two issues and would be of one-year duration but would be the longest trial of testosterone therapy in men with cardiovascular disease
The primary endpoint is change in time to ST- segment depression of 1mm during exercise testing
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