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Study of Sildenafil in Patient With Heart Failure.

This study has been completed.
Sponsor:
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
  Purpose

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


Condition Intervention Phase
Congestive Heart Failure
 Drug: sildenafil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

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

Estimated Enrollment: 40
Study Start Date: December 2001
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309816

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

No publications provided

ClinicalTrials.gov Identifier: NCT00309816     History of Changes
Other Study ID Numbers: 2001-p-001039
Study First Received: March 30, 2006
Last Updated: March 30, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Exercise stress test

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013