Back to resultsStudy of Sildenafil in Patient With Heart Failure.
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Exercise stress test
Eligibility Criteria
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 -
Sites / Locations
- Massachusetts General Hospital
Outcomes
Primary Outcome Measures
Patients will have exercise capacity measured by an exercise stress test before and after one dose of sildenafil.
Secondary Outcome Measures
Full Information
NCT ID
NCT00309816
First Posted
March 30, 2006
Last Updated
March 30, 2006
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00309816
Brief Title
Study of Sildenafil in Patient With Heart Failure.
Official Title
Measurement of the Effect of Sildenafil Citrate (Viagra) on the Hemodynamics of Exercise Tolerance in Advanced Congestive Heart Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if sildenafil (Viagra) improves exercise tolerance.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Exercise stress test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sildenafil
Primary Outcome Measure Information:
Title
Patients will have exercise capacity measured by an exercise stress test before and after one dose of sildenafil.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc J Semigran, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Sildenafil in Patient With Heart Failure.
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