[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423700":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":85,"collaborators":87,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":30,"enrollmentInfo":102,"targetDuration":30,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":69,"whyStopped":30,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sildenafil","EXPERIMENTAL","Sildenafil 20 mg by mouth three(3) times each day",[13],"Drug: Sildenafil",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo by mouth three(3) times each day",[19],"Other: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Sildenafil 20 mg three times a day. This is the approved dose for the treatment of pulmonary arterial hypertension. It is being studied in this trial with a population who has mildly elevated pulmonary pressures.",[9],[26],"Revatio, Viagra",{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Oral pill placebo.",[15],null,[32],{"name":33,"affiliation":5,"role":34},"Stephen Mathai, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":30,"email":39},"CONTACT","4106146311","smathai4@jhmi.edu",{"name":41,"role":37,"phone":42,"phoneExt":30,"email":43},"Renee Ofori","410-614-6311","rofori2@jhu.edu",[45,67],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Louisiana State University","NOT_YET_RECRUITING","New Orleans","Louisiana","70806","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-90.07507,29.95465,{"lat":57,"lon":56},[60,63,66],{"name":61,"role":37,"phone":62,"phoneExt":30,"email":30},"Matthew Lammi, MD","504-568-4634",{"name":64,"role":37,"phone":30,"phoneExt":30,"email":65},"Marie Sandi","mchild@lsuhsc.edu",{"name":61,"role":34,"phone":30,"phoneExt":30,"email":30},{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":51,"countryCode":52,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Johns Hopkins","RECRUITING","Baltimore","Maryland","21287",{"type":54,"coordinates":74},[75,76],-76.61219,39.29038,{"lat":76,"lon":75},[79,80,84],{"name":33,"role":37,"phone":42,"phoneExt":30,"email":39},{"name":81,"role":37,"phone":82,"phoneExt":30,"email":83},"Dezeray Dutton","4435078222","dcephas1@jhu.edu",{"name":33,"role":34,"phone":30,"phoneExt":30,"email":30},{"type":86,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[88,90],{"name":89,"class":6},"Louisiana State University Health Sciences Center in New Orleans",{"name":91,"class":92},"United States Department of Defense","FED","100423700","phase-2-sildenafil-for-early-pulmonary-vascular-disease-in-scleroderma-100423700",false,"NCT04797286","Sildenafil for Early Pulmonary Vascular Disease in Scleroderma","SEPVADIS","Inclusion Criteria:\n\n* Previous documentation of mean pulmonary artery pressure between 21 and 24 mm Hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) ≤ 15 mm Hg within six months before study entry.\n* Diagnosis of SSc according to 2013 American College of Rheumatology\u002F European League Against Rheumatism (ACR\u002FEULAR) classification criteria.\n* Pulmonary function tests with forced expiratory volume in one second\u002Fforced vital capacity (FEV1\u002FFVC) \\>50% AND either a) total lung capacity (TLC) or forced vital capacity (FVC) \\> 70% predicted or b) TLC or FVC between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest on studies obtained within 6 months of enrollment.\n* Ventilation perfusion scan or computed tomography with intravenous contrast (CT angiogram) without evidence of chronic thromboembolism at anytime before study entry.\n* Ability to perform six minute walk testing without significant limitations in musculoskeletal function or coordination.\n* Informed consent.\n\nExclusion Criteria:\n\n* World Health Organization (WHO) Class IV functional status.\n* Systolic blood pressure less than 90 mmHg at screening visit prior to enrollment.\n* Clinically significant untreated sleep apnea.\n* Left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction \\\u003C 45% on most recent echocardiography (within 1 year).\n* Use of Pulmonary Arterial Hypertension (PAH) therapy (prostacyclin analogues, endothelin-1 receptor antagonists,phosphodiesterase-5 inhibitors, riociguat, selexipag) within the past 3 months.\n* Hospitalized or acutely ill.\n* Renal failure (creatinine above 2.0) at screening visit.\n* Enrollment in a clinical trial or concurrent use of another investigational drug (non FDA approved) or device therapy within 30 days of screening visit.\n* Age \\\u003C 18.\n* Currently pregnant.\n* Current use of nitrates.","ALL","18 Years",{"count":103,"type":104},30,"ESTIMATED","INTERVENTIONAL",[107],"PHASE2","This is a Phase II randomized, double-blind, placebo-controlled trial of sildenafil in men and women with Scleroderma with mildly elevated pulmonary pressures (SSc-MEP) to determine whether sildenafil may be an effective treatment for SSc-MEP.",[110,111],"Scleroderma","Mildly Elevated Pulmonary Pressures",[113],"SSc-MEP","2025-10-13",{"date":116,"type":117},"2025-10-15","ACTUAL",{"date":119,"type":117},"2021-09-20",{"date":121,"type":104},"2026-09-01",{"name":5,"class":6},2]