Study of Sildenafil in Advanced Heart Failure.

Phase 3

Completed

• Conditions: Congestive Heart Failure

• Registration Number: NCT00309790
• Lead Sponsor: Massachusetts General Hospital

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.

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.

Study Timeline

• Study Start: 2003-05
• Study Completion: 2006-03
• Study First Submitted: 2006-03-30
• Study First Submitted QC: 2006-03-30
• Study First Posted: 2006-04-03
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-07
• Last Update Posted: 2009-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Age >18 years Ejection fraction <40% Heart failure limited by fatigue and shortness of breath Pulmonary artery hypertension

Exclusion Criteria

Patients taking the following medications: nitroglycerine pill/patch/paste, isordil, Imdur, antifungal agents and certain antidepressants.

Patients with a history of optic neuropathy or unexplained visual impairment. Patients with anemia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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