Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413244
Status:
COMPLETED
Last Update Posted:
2017-01-05
First Post:
2006-12-18
Brief Title:
The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
The Cardiac Benefit of Androgen Replacement in Hypogonadal Males With Coronary Artery Disease Following Successful Percutaneous Coronary Intervention PCI
Status:
COMPLETED
Status Verified Date:
2016-11
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:
The purpose of the study is to find out if giving the study drug Androgel testosterone as a testosterone replacement help bring the testosterone to an acceptable level and to find out if it will help improve heart condition in males with coronary artery disease CAD following successful percutaneous coronary intervention
Detailed Description:
Males with coronary heart disease have lower serum levels of bioavailable testosterone than men of a similar age with normal coronary angiograms English European Heart Journal 2000 Low plasma testosterone has been associated with known risk factors for CHD including age obesity hyperinsulinemia diabetes and adverse lipid profile
Testosterone has also been shown in numerous studies to be a vasodilator Recently testosterone replacement compared with placebo in hypogonadal men was shown to improve time to ischemic threshold assessed by treadmill exercise testing at 4 and 12 weeks Malkin Heart 2000 Prior studies had also shown a beneficial effect on exercise-induced ischemia in men with CAD but not exclusively hypogonadal men JaffeBr Heart J 1977 Rosano Circulation 1999 English Circulation 2000 In addition this proposed study would be the first study to assess if the anti-anginal effects persists long term
This is a randomized double-blind placebo-controlled study to evaluate the safety and efficacy of testosterone supplementation in hypogonadal men with coronary artery disease following successful revascularization with percutaneous coronary intervention PCI Only those men who had successful coronary artery revascularization and on stable cardiac medical regimen for the prior 4 weeks will be included Eligible patients will then be randomized on a 21 basis with 50 subjects receiving 5 grams of AndroGel and 25 subjects receiving placebo gel
The men in this study who demonstrate hypogonadism represent a novel population to demonstrate the safety and efficacy of testosterone supplementation to improve cardiac function and outcomes We hypothesize that treatment of hypogonadism in men with CAD following successful PCI will significantly improve cardiac ischemic threshold as assessed by cardiac stress testing Furthermore additional cardiac endpoints such as angina status endothelial function and inflammatory serum markers will also demonstrate significant benefit in the testosterone treated group
Testosterone has also been shown in numerous studies to be a vasodilator Recently testosterone replacement compared with placebo in hypogonadal men was shown to improve time to ischemic threshold assessed by treadmill exercise testing at 4 and 12 weeks Malkin Heart 2000 Prior studies had also shown a beneficial effect on exercise-induced ischemia in men with CAD but not exclusively hypogonadal men JaffeBr Heart J 1977 Rosano Circulation 1999 English Circulation 2000 In addition this proposed study would be the first study to assess if the anti-anginal effects persists long term
This is a randomized double-blind placebo-controlled study to evaluate the safety and efficacy of testosterone supplementation in hypogonadal men with coronary artery disease following successful revascularization with percutaneous coronary intervention PCI Only those men who had successful coronary artery revascularization and on stable cardiac medical regimen for the prior 4 weeks will be included Eligible patients will then be randomized on a 21 basis with 50 subjects receiving 5 grams of AndroGel and 25 subjects receiving placebo gel
The men in this study who demonstrate hypogonadism represent a novel population to demonstrate the safety and efficacy of testosterone supplementation to improve cardiac function and outcomes We hypothesize that treatment of hypogonadism in men with CAD following successful PCI will significantly improve cardiac ischemic threshold as assessed by cardiac stress testing Furthermore additional cardiac endpoints such as angina status endothelial function and inflammatory serum markers will also demonstrate significant benefit in the testosterone treated group
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