Back to resultsStudy of Sildenafil in Advanced Heart Failure.
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring exercise stress test
Eligibility Criteria
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. -
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00309790
First Posted
March 30, 2006
Last Updated
August 7, 2009
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00309790
Brief Title
Study of Sildenafil in Advanced Heart Failure.
Official Title
Phase 3 Study of the Effects of Chronic Sildenafil Citrate Therapy on Exercise Tolerance and Hemodynamics in Patients With Advanced Heart Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
exercise stress test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sildenafil
Primary Outcome Measure Information:
Title
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
Title
quality of life measured by questionnaires at baseline and at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc J Semigran, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
27301469
Citation
Malhotra R, Dhakal BP, Eisman AS, Pappagianopoulos PP, Dress A, Weiner RB, Baggish AL, Semigran MJ, Lewis GD. Pulmonary Vascular Distensibility Predicts Pulmonary Hypertension Severity, Exercise Capacity, and Survival in Heart Failure. Circ Heart Fail. 2016 Jun;9(6):10.1161/CIRCHEARTFAILURE.115.003011 e003011. doi: 10.1161/CIRCHEARTFAILURE.115.003011.
Results Reference
derived
PubMed Identifier
21875912
Citation
Murphy RM, Shah RV, Malhotra R, Pappagianopoulos PP, Hough SS, Systrom DM, Semigran MJ, Lewis GD. Exercise oscillatory ventilation in systolic heart failure: an indicator of impaired hemodynamic response to exercise. Circulation. 2011 Sep 27;124(13):1442-51. doi: 10.1161/CIRCULATIONAHA.111.024141. Epub 2011 Aug 29.
Results Reference
derived
PubMed Identifier
21292991
Citation
Lewis GD, Murphy RM, Shah RV, Pappagianopoulos PP, Malhotra R, Bloch KD, Systrom DM, Semigran MJ. Pulmonary vascular response patterns during exercise in left ventricular systolic dysfunction predict exercise capacity and outcomes. Circ Heart Fail. 2011 May;4(3):276-85. doi: 10.1161/CIRCHEARTFAILURE.110.959437. Epub 2011 Feb 3.
Results Reference
derived
Learn more about this trial
Study of Sildenafil in Advanced Heart Failure.
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