Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)

• Status: Terminated
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Sildenafil Citrate

Criteria

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