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

Asan Medical Center

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Hypertension, Pulmonary; Diseases of Mitral Valve

Treatments: Drug: Placebo; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT02435303

MVsurgery_PAH

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2 participants in 2 patient groups, including a placebo group

Sildenafil

Experimental group

Description:

Sildenafil 20mg tid for six months (\* consider open-label extension study for 1 year)

Treatment:

Drug: Sildenafil

Placebo

Placebo Comparator group

Description:

Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil

Treatment:

Drug: Placebo