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

NCT ID: NCT02435303

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension, Pulmonary Diseases of Mitral Valve

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sildenafil

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

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sildenafil

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Viagra, Revatio, others

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jong-Min Song

Professor, University of Ulsan College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jong-Min Song

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MVsurgery_PAH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sildenafil in Single Ventricle Patients
NCT01169519 COMPLETED PHASE1
Sildenafil and Pulmonary Artery Pressure
NCT00145938 TERMINATED PHASE2