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

Effect of Sildenafil for the Treatment of Sustained Pulmonary Artery Hypertension After Corrected Mitral Valve Disease

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02435303

Acronym

SUPERIOR

Enrollment

Registered

2015-05-06

Start date

2016-05-31

Completion date

2018-06-30

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of Mitral Valve, Hypertension, Pulmonary

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.

Interventions

DRUGSildenafil

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Change of Six Minutes Walk Distance	baseline and six months	unit of measure : meter (m)

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026