Study of Sildenafil in Patient With Heart Failure.
This study has been completed.
Sponsor:
Massachusetts General Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00309816
First received: March 30, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 30, 2006 | ||||
| Last Updated Date | March 30, 2006 | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Congestive Heart Failure | ||||
| Intervention ICMJE | Drug: sildenafil | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* 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 | ||||
| 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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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00309816 | ||||
| Other Study ID Numbers ICMJE | 2001-p-001039 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | March 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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