Study of Sildenafil in Advanced Heart Failure.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00309790
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	Phase 3
Start date	May 2003
Completion date	March 2006

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