NCT02435303TerminatedPhase 2
Effect of Sildenafil for the Treatment of Sustained Pulmonary Artery Hypertension After Corrected Mitral Valve Disease
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Asan Medical Center
- Enrollment
- 2
- Primary Endpoint
- Change of Six Minutes Walk Distance
Study Overview
Brief Summary
The purpose of this study is to determine whether Sildenafil is effective in the treatment of sustained pulmonary artery hypertension after corrected mitral valve disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •New York Heart Association Functional class (NYHA Fc) ≥ 2 dyspnea which was sustained till one year after the previous mitral valve surgery (repair or replacement)
- •TR Vmax ≥ 3.5m/s by echocardiography
- •Normal left ventricle ejection fraction (EF ≥ 50%)
- •Pulmonary vascular resistance ≥ 3 Wood Unit or diastolic pressure gradient ≥ 7mmHg by cardiac catheterization
Exclusion Criteria
- •Other valve disease more than moderate degree (ex. aortic stenosis, aortic regurgitation)
- •Liver cirrhosis
- •Chronic renal failure with serum creatinine ≥ 1.7mg/dL
- •Lung disease (ex. chronic obstructive pulmonary disease, Asthma)
- •Thyroid dysfunction
- •Other causes which can lead to pulmonary hypertension
Arms & Interventions
Sildenafil
Experimental
Sildenafil 20mg tid for six months (* consider open-label extension study for 1 year)
Intervention: Sildenafil (Drug)
Placebo
Placebo Comparator
Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change of Six Minutes Walk Distance
Time Frame: baseline and six months
unit of measure : meter (m)
Secondary Outcomes
- Pulmonary vascular resistance (PVR) measured by cardiac catheterization(six months)
- Borg dyspnea score(six months)
- Systolic pulmonary artery pressure measured by cardiac catheterization(six months)
- Fractional area change of right ventricle measured by echocardiography(six months)
- Exercise capacity by cardiopulmonary exercise test(six months)
- Mean pulmonary artery pressure measured by cardiac catheterization(six months)
Investigators
Jong-Min Song
Professor, University of Ulsan College of Medicine
Asan Medical Center
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