Study of Sildenafil in Advanced Heart Failure.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Phase 3 Study of the Effects of Chronic Sildenafil Citrate Therapy on Exercise Tolerance and Hemodynamics in Patients With Advanced Heart Failure.|
- Patients will have the following performed at baseline and again after taking study medication for 12 weeks: exercise capacity measured by exercise stress test, heart pressure measured by a heart catheterization and
- quality of life measured by questionnaires at baseline and at 12 weeks
|Study Start Date:||May 2003|
|Study Completion Date:||March 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309790
|Principal Investigator:||Marc J Semigran, MD||Massachusetts General Hospital|