Study of Sildenafil in Patient With Heart Failure.

Tracking Information
First Submitted Date ICMJE	March 30, 2006
First Posted Date ICMJE	April 3, 2006
Last Update Posted Date	April 3, 2006
Study Start Date ICMJE	December 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: March 30, 2006)	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.
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 ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Congestive Heart Failure
Intervention ICMJE	Drug: sildenafil
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: March 30, 2006)	40
Original Enrollment ICMJE	Same as current
Study 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00309816
Other Study ID Numbers ICMJE	2001-p-001039
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Massachusetts General Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Marc J Semigran, MD Massachusetts General Hospital
PRS Account	Massachusetts General Hospital
Verification Date	March 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP