Study of Sildenafil in Patient With Heart Failure.
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ClinicalTrials.gov Identifier: NCT00309816 |
Recruitment Status
:
Completed
First Posted
: April 3, 2006
Last Update Posted
: April 3, 2006
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Sponsor:
Massachusetts General Hospital
Information provided by:
Massachusetts General Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | March 30, 2006 | |||
First Posted Date ICMJE | April 3, 2006 | |||
Last Update Posted Date | April 3, 2006 | |||
Study Start Date ICMJE | December 2001 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Patients will have exercise capacity measured by an exercise stress test before and after one dose of sildenafil. | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Sildenafil in Patient With Heart Failure. | |||
Official Title ICMJE | Measurement of the Effect of Sildenafil Citrate (Viagra) on the Hemodynamics of Exercise Tolerance in Advanced Congestive Heart Failure. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Congestive Heart Failure | |||
Intervention ICMJE | Drug: sildenafil | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
40 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date | February 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | 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 |
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00309816 | |||
Other Study ID Numbers ICMJE | 2001-p-001039 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Massachusetts General Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | March 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |