Back to resultsEffect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial) (SUPERIOR)
Primary Purpose
Hypertension, Pulmonary, Diseases of Mitral Valve
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sildenafil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sildenafil
Placebo
Arm Description
Sildenafil 20mg tid for six months (* consider open-label extension study for 1 year)
Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil
Outcomes
Primary Outcome Measures
Change of Six Minutes Walk Distance
unit of measure : meter (m)
Secondary Outcome Measures
Borg dyspnea score
Exercise capacity by cardiopulmonary exercise test
Fractional area change of right ventricle measured by echocardiography
unit of measure : percent (%)
Pulmonary vascular resistance (PVR) measured by cardiac catheterization
unit of measure : wood unit (WU)
Systolic pulmonary artery pressure measured by cardiac catheterization
unit of measure : pressure (mmHg)
Mean pulmonary artery pressure measured by cardiac catheterization
unit of measure : pressure (mmHg)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02435303
Brief Title
Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)
Acronym
SUPERIOR
Official Title
Effect of Sildenafil for the Treatment of Sustained Pulmonary Artery Hypertension After Corrected Mitral Valve Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Number of candidates for this study is expected to be too small.
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary, Diseases of Mitral Valve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil
Arm Type
Experimental
Arm Description
Sildenafil 20mg tid for six months (* consider open-label extension study for 1 year)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Viagra, Revatio, others
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change of Six Minutes Walk Distance
Description
unit of measure : meter (m)
Time Frame
baseline and six months
Secondary Outcome Measure Information:
Title
Borg dyspnea score
Time Frame
six months
Title
Exercise capacity by cardiopulmonary exercise test
Time Frame
six months
Title
Fractional area change of right ventricle measured by echocardiography
Description
unit of measure : percent (%)
Time Frame
six months
Title
Pulmonary vascular resistance (PVR) measured by cardiac catheterization
Description
unit of measure : wood unit (WU)
Time Frame
six months
Title
Systolic pulmonary artery pressure measured by cardiac catheterization
Description
unit of measure : pressure (mmHg)
Time Frame
six months
Title
Mean pulmonary artery pressure measured by cardiac catheterization
Description
unit of measure : pressure (mmHg)
Time Frame
six months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Min Song
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)
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