[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mildly-elevated-pulmonary-pressures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mildly-elevated-pulmonary-pressures":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Scleroderma","Mildly Elevated Pulmonary Pressures",[29],"SSc-MEP","RECRUITING","2025-10-13",{"date":33,"type":34},"2025-10-15","ACTUAL",{"date":36,"type":34},"2021-09-20",{"date":38,"type":20},"2026-09-01",{"name":40,"class":41},"Johns Hopkins University","OTHER",2]