Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309790
Status:
COMPLETED
Last Update Posted:
2009-08-11
First Post:
2006-03-30
Brief Title:
Study of Sildenafil in Advanced Heart Failure
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase 3 Study of the Effects of Chronic Sildenafil Citrate Therapy on Exercise Tolerance and Hemodynamics in Patients With Advanced Heart Failure
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite advances in medical therapy for patients with heart failure one-third of patients remain limited by fatigue and shortness of breath
Our previous study concluded that one dose of sildenafil Viagra lead to an improvement in heart pressure and exercise capacity
Currently sildenafil is not FDA approved for the treatment of heart failure
The purpose of this study is to determine if treatment with sildenafil for 12 weeks in patients with heart failure can improve exercise capacity and quality of life in people with heart failure
Our previous study concluded that one dose of sildenafil Viagra lead to an improvement in heart pressure and exercise capacity
Currently sildenafil is not FDA approved for the treatment of heart failure
The purpose of this study is to determine if treatment with sildenafil for 12 weeks in patients with heart failure can improve exercise capacity and quality of life in people with heart failure
Detailed Description:
This study will compare two groups of patients One group will receive sildenafil and the other group will receive a placebo a pill which looks like sildenafil but contains no medication
Patients will undergo a heart catheterization echocardiogram and exercise stress test Patients will then take study medication for 12 weeks A repeat heart catheterization echocardiogram and exercise stress test will then be performed
Patients will undergo a heart catheterization echocardiogram and exercise stress test Patients will then take study medication for 12 weeks A repeat heart catheterization echocardiogram and exercise stress test will then be performed
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