Study Stopped
Number of candidates for this study is expected to be too small.
Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)
SUPERIOR
Effect of Sildenafil for the Treatment of Sustained Pulmonary Artery Hypertension After Corrected Mitral Valve Disease
1 other identifier
interventional
2
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJuly 5, 2019
July 1, 2019
2.1 years
April 28, 2015
July 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Six Minutes Walk Distance
unit of measure : meter (m)
baseline and six months
Secondary Outcomes (6)
Borg dyspnea score
six months
Exercise capacity by cardiopulmonary exercise test
six months
Fractional area change of right ventricle measured by echocardiography
six months
Pulmonary vascular resistance (PVR) measured by cardiac catheterization
six months
Systolic pulmonary artery pressure measured by cardiac catheterization
six months
- +1 more secondary outcomes
Study Arms (2)
Sildenafil
EXPERIMENTALSildenafil 20mg tid for six months (\* consider open-label extension study for 1 year)
Placebo
PLACEBO COMPARATORPlacebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong-Min Song
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, University of Ulsan College of Medicine
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 6, 2015
Study Start
May 1, 2016
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
July 5, 2019
Record last verified: 2019-07