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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
Information provided by:
Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: sildenafil Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measurement of the Effect of Sildenafil Citrate (Viagra) on the Hemodynamics of Exercise Tolerance in Advanced Congestive Heart Failure.
Study Start Date : December 2001
Estimated Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Patients will have exercise capacity measured by an exercise stress test before and after one dose of sildenafil.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309816

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Marc J Semigran, MD Massachusetts General Hospital

ClinicalTrials.gov Identifier: NCT00309816     History of Changes
Other Study ID Numbers: 2001-p-001039
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: April 3, 2006
Last Verified: March 2006

Keywords provided by Massachusetts General Hospital:
Exercise stress test

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents