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

Phase 2

Terminated

• Conditions: Hypertension, Pulmonary; Diseases of Mitral Valve
• Interventions: Drug: Placebo; Drug: Sildenafil

• Registration Number: NCT02435303
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-05-01
• Study First Posted: 2015-05-06
• Study Start: 2016-05
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil
Sildenafil	Sildenafil	Sildenafil 20mg tid for six months (\* consider open-label extension study for 1 year)

Primary Outcome Measures

Name	Time	Method
Change of Six Minutes Walk Distance	baseline and six months	unit of measure : meter (m)

Secondary Outcome Measures

Name	Time	Method
Pulmonary vascular resistance (PVR) measured by cardiac catheterization	six months	unit of measure : wood unit (WU)
Borg dyspnea score	six months
Systolic pulmonary artery pressure measured by cardiac catheterization	six months	unit of measure : pressure (mmHg)
Fractional area change of right ventricle measured by echocardiography	six months	unit of measure : percent (%)
Exercise capacity by cardiopulmonary exercise test	six months
Mean pulmonary artery pressure measured by cardiac catheterization	six months	unit of measure : pressure (mmHg)