Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)
NCT ID: NCT02435303
Last Updated: 2019-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
2 participants
INTERVENTIONAL
2016-05-31
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sildenafil
Sildenafil 20mg tid for six months (\* consider open-label extension study for 1 year)
Sildenafil
Placebo
Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil
Placebo
Interventions
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Sildenafil
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Jong-Min Song
Professor, University of Ulsan College of Medicine
Principal Investigators
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Jong-Min Song
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Other Identifiers
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MVsurgery_PAH
Identifier Type: -
Identifier Source: org_study_id
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