Study of Sildenafil in Advanced Heart Failure.

Congestive Heart Failure Clinical Trial

Official title:

Phase 3 Study of the Effects of Chronic Sildenafil Citrate Therapy on Exercise Tolerance and Hemodynamics in Patients With Advanced Heart Failure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309790
• Other study ID #: 2003-p-0003994
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2006
• Last updated: August 7, 2009
• Start date: May 2003
• Est. completion date: March 2006

Study information

• Verified date: August 2009
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• sildenafil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	quality of life measured by questionnaires at baseline and at 12 weeks