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
|First Submitted Date ICMJE||March 30, 2006|
|First Posted Date ICMJE||April 3, 2006|
|Last Update Posted Date||August 11, 2009|
|Study Start Date ICMJE||May 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00309790 on ClinicalTrials.gov Archive Site|
|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|
|Brief Title ICMJE||Study of Sildenafil in Advanced Heart Failure.|
|Official Title ICMJE||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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Congestive Heart Failure|
|Intervention ICMJE||Drug: sildenafil|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Same as current|
|Actual Study Completion Date||March 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Age >18 years Ejection fraction <40% Heart failure limited by fatigue and shortness of breath Pulmonary artery hypertension
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.
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries||United States|
|NCT Number ICMJE||NCT00309790|
|Other Study ID Numbers ICMJE||2003-p-0003994|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Marc J Semigran, MD, Massachusetts General Hospital|
|Study Sponsor ICMJE||Massachusetts General Hospital|
|Collaborators ICMJE||Not Provided|
|PRS Account||Massachusetts General Hospital|
|Verification Date||August 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP