Status:
TERMINATED
Sildenafil in Heart Failure With Reactive Pulmonary Hypertension
Lead Sponsor:
Maya Guglin
Conditions:
Heart Failure With Reactive Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a double-blind, p...
Detailed Description
Patients will be screened at the time of a diagnositic Right Heart Catheterization. Patients will be selected based on pressures measured during this procedure, current medications, and current sympto...
Eligibility Criteria
Inclusion
- Known chronic heart failure appropriately treated with Angiotensin converting enzyme (ACE) inhibitors and beta blockers, unless contraindicated or poorly tolerated
- indication for right heart catheterization
- pulmonary artery mean pressure \>25 mmHg
- pulmonary capillary wedge pressure \> 15 mmHg
- pulmonary vascular resistance \> 3 Wood units
Exclusion
- hypersensitivity, allergy, or intolerable side effect to sildenafil
- history of primary pulmonary hypertension, connective tissue disorder, severe chronic obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt
- co-morbidities, limited exercise intolerance:
- morbid obesity (BMI \>40)
- COPD with oxygen dependence
- severe peripheral vascular disease with intermittent claudication
- status post amputation of lower extremity at any level
- severe degenerative joint disease preventing normal walking
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02304705
Start Date
January 1 2015
End Date
June 1 2017
Last Update
November 7 2019
Active Locations (1)
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1
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536