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Study of Sildenafil in Advanced Heart Failure.

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ClinicalTrials.gov Identifier: NCT00309790
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : August 11, 2009
Sponsor:
Information provided by:

March 30, 2006
April 3, 2006
August 11, 2009
May 2003
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  • Patients will have the following performed at baseline and again after taking study medication for 12 weeks: exercise capacity measured by exercise stress test, heart pressure measured by a heart catheterization and
  • quality of life measured by questionnaires at baseline and at 12 weeks
Same as current
Complete list of historical versions of study NCT00309790 on ClinicalTrials.gov Archive Site
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Study of Sildenafil in Advanced Heart Failure.
Phase 3 Study of the Effects of Chronic Sildenafil Citrate Therapy on Exercise Tolerance and Hemodynamics in Patients With Advanced Heart Failure.

Despite advances in medical therapy for patients with heart failure, one-third of patients remain limited by fatigue and shortness of breath.

Our previous study concluded that one dose of sildenafil (Viagra) lead to an improvement in heart pressure and exercise capacity.

Currently sildenafil is not FDA approved for the treatment of heart failure.

The purpose of this study is to determine if treatment with sildenafil for 12 weeks in patients with heart failure can improve exercise capacity and quality of life in people with heart failure.

This study will compare two groups of patients. One group will receive sildenafil and the other group will receive a placebo (a pill which looks like sildenafil, but contains no medication).

Patients will undergo a heart catheterization, echocardiogram and exercise stress test. Patients will then take study medication for 12 weeks. A repeat heart catheterization, echocardiogram and exercise stress test will then be performed.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Congestive Heart Failure
Drug: sildenafil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2006
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Inclusion Criteria:

Age >18 years Ejection fraction <40% Heart failure limited by fatigue and shortness of breath Pulmonary artery hypertension

Exclusion Criteria:

Patients taking the following medications: nitroglycerine pill/patch/paste, isordil, Imdur, antifungal agents and certain antidepressants.

Patients with a history of optic neuropathy or unexplained visual impairment. Patients with anemia.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00309790
2003-p-0003994
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Marc J Semigran, MD, Massachusetts General Hospital
Massachusetts General Hospital
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Principal Investigator: Marc J Semigran, MD Massachusetts General Hospital
Massachusetts General Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP