Study of Sildenafil in Patient With Heart Failure.

Congestive Heart Failure Clinical Trial

Official title:

Measurement of the Effect of Sildenafil Citrate (Viagra) on the Hemodynamics of Exercise Tolerance in Advanced Congestive Heart Failure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309816
• Other study ID #: 2001-p-001039
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2006
• Last updated: March 30, 2006
• Start date: December 2001
• Est. completion date: February 2006

Study information

• Verified date: March 2006
• 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

The purpose of this study is to determine if sildenafil (Viagra) improves exercise tolerance.

Description:

Patients will undergo an exercise stress test. One dose of Sildenafil will then be given, followed by a one hour rest period. A repeat exercise stress test will then be repeated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Age 18 - 75 Ejection fraction <35% Heart failure limited by fatigue and shortness of breath -

Exclusion Criteria:

Inability to exercise. Patients with shortness of breath while resting. Patient requiring intravenous medication. Patients taking the following medications: nitroglycerine pill/patch/paste, isordil and Imdur

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• sildenafil

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients will have exercise capacity measured by an exercise stress test before and after one dose of sildenafil.