Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-02-27 @ 11:55 PM
Study NCT ID:
NCT02435303
Status:
TERMINATED
Last Update Posted:
2019-07-05
First Post:
2015-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Number of candidates for this study is expected to be too small.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2015-04-28', 'studyFirstSubmitQcDate': '2015-05-01', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Six Minutes Walk Distance', 'timeFrame': 'baseline and six months', 'description': 'unit of measure : meter (m)'}], 'secondaryOutcomes': [{'measure': 'Borg dyspnea score', 'timeFrame': 'six months'}, {'measure': 'Exercise capacity by cardiopulmonary exercise test', 'timeFrame': 'six months'}, {'measure': 'Fractional area change of right ventricle measured by echocardiography', 'timeFrame': 'six months', 'description': 'unit of measure : percent (%)'}, {'measure': 'Pulmonary vascular resistance (PVR) measured by cardiac catheterization', 'timeFrame': 'six months', 'description': 'unit of measure : wood unit (WU)'}, {'measure': 'Systolic pulmonary artery pressure measured by cardiac catheterization', 'timeFrame': 'six months', 'description': 'unit of measure : pressure (mmHg)'}, {'measure': 'Mean pulmonary artery pressure measured by cardiac catheterization', 'timeFrame': 'six months', 'description': 'unit of measure : pressure (mmHg)'}]}, 'conditionsModule': {'conditions': ['Hypertension, Pulmonary', 'Diseases of Mitral Valve']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* TR Vmax ≥ 3.5m/s by echocardiography\n* Normal left ventricle ejection fraction (EF ≥ 50%)\n* Pulmonary vascular resistance ≥ 3 Wood Unit or diastolic pressure gradient ≥ 7mmHg by cardiac catheterization\n\nExclusion Criteria:\n\n* Other valve disease more than moderate degree (ex. aortic stenosis, aortic regurgitation)\n* Liver cirrhosis\n* Chronic renal failure with serum creatinine ≥ 1.7mg/dL\n* Lung disease (ex. chronic obstructive pulmonary disease, Asthma)\n* Thyroid dysfunction\n* Other causes which can lead to pulmonary hypertension'}, 'identificationModule': {'nctId': 'NCT02435303', 'acronym': 'SUPERIOR', 'briefTitle': 'Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Effect of Sildenafil for the Treatment of Sustained Pulmonary Artery Hypertension After Corrected Mitral Valve Disease', 'orgStudyIdInfo': {'id': 'MVsurgery_PAH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sildenafil', 'description': 'Sildenafil 20mg tid for six months (\\* consider open-label extension study for 1 year)', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Viagra, Revatio, others'], 'armGroupLabels': ['Sildenafil']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jong-Min Song', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, University of Ulsan College of Medicine', 'investigatorFullName': 'Jong-Min Song', 'investigatorAffiliation': 'Asan Medical Center'}}}}