[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657470":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":54,"studyPopulation":46,"armGroups":55,"interventions":68,"overallOfficials":77,"centralContacts":81,"locations":91,"responsibleParty":115,"collaborators":46,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":46,"enrollmentInfo":127,"targetDuration":46,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":94,"whyStopped":46,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Valley Health System","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Exercise Pulmonary Vascular Resistance (PVR)","Change in exercise pulmonary vascular resistance (PVR) from baseline to Month 6, measured during exercise right heart catheterization with invasive cardiopulmonary exercise testing (iCPET). The primary analysis will compare the change in exercise PVR between the inhaled treprostinil and standard-of-care groups","Baseline to Month 6",[14,18,22,25,28,31,34,37,40,43],{"measure":15,"description":16,"timeFrame":17},"Incidence of Adverse Events and Treatment Discontinuations","Incidence of adverse events, serious adverse events, treatment discontinuations, and medication tolerability during treatment with inhaled treprostinil.","Through Month 6",{"measure":19,"description":20,"timeFrame":21},"Progression to Resting Pulmonary Hypertension","Proportion of participants who develop resting pulmonary hypertension at Month 12, defined as resting mean pulmonary artery pressure (mPAP) \\>20 mmHg and pulmonary vascular resistance (PVR) \\>2 Wood Units measured by right heart catheterization","Month 12",{"measure":23,"description":24,"timeFrame":21},"Change in Exercise Pulmonary Vascular Resistance (PVR) at Month 12","Change in exercise pulmonary vascular resistance (PVR), measured in Wood Units (WU), from baseline to Month 12 among participants continuing in the extension phase.",{"measure":26,"description":27,"timeFrame":12},"Change in Right Ventricular Stroke Work Index (RVSWI) at Month 6","Change in right ventricular stroke work index (RVSWI) from baseline to Month 6, measured during exercise right heart catheterization with invasive cardiopulmonary exercise testing (iCPET). The primary analysis will compare the change in RVSWI between the inhaled treprostinil and standard-of-care groups.",{"measure":29,"description":30,"timeFrame":12},"Change in Pulmonary Arterial Compliance at Month 6","Change in pulmonary arterial compliance from baseline to Month 6, measured during exercise right heart catheterization with invasive cardiopulmonary exercise testing (iCPET). The primary analysis will compare the change in pulmonary arterial compliance between the inhaled treprostinil and standard-of-care groups.",{"measure":32,"description":33,"timeFrame":12},"Change in 6-Minute Walk Distance at Month 6","Change in 6-minute walk distance (meters) from baseline to Month 6. The analysis will compare the change between the inhaled treprostinil and standard-of-care groups.",{"measure":35,"description":36,"timeFrame":12},"Change in Dyspnea Severity (Borg Scale) at Month 6","Change from baseline to Month 6 in dyspnea severity measured using the Borg Category Ratio (CR10) Dyspnea Scale. Scores range from 0 to 10, where 0 indicates no breathlessness and 10 indicates maximal breathlessness. Higher scores indicate worse dyspnea.",{"measure":38,"description":39,"timeFrame":21},"Change in 6-Minute Walk Distance at Month 12","Change in 6-minute walk distance, measured in meters, from baseline to Month 12 among participants continuing in the extension phase.",{"measure":41,"description":42,"timeFrame":12},"Change in Mean Pulmonary Artery Pressure\u002FCardiac Output (mPAP\u002FCO) Slope at Month 6","Change in mPAP\u002FCO slope from baseline to Month 6, measured during exercise right heart catheterization with invasive cardiopulmonary exercise testing (iCPET). The analysis will compare the change between the inhaled treprostinil and standard-of-care groups.",{"measure":44,"description":45,"timeFrame":21},"Change in Dyspnea Severity (Borg Category Ratio [CR10] Dyspnea Scale) at Month 12","Change from baseline to Month 12 in dyspnea severity measured using the Borg Category Ratio (CR10) Dyspnea Scale. Scores range from 0 to 10, with higher scores indicating worse dyspnea.",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":46,"timePerspective":46,"maskingInfo":52},"NON_RANDOMIZED","PARALLEL","Parallel, open-label, matched-control pilot study comparing inhaled treprostinil plus standard of care versus standard of care alone in adults with exercise-induced pulmonary hypertension","TREATMENT",{"masking":53,"maskingDescription":46,"whoMasked":46},"NONE","1.1 Purpose\u002FSpecific Aims This pilot study aims to determine whether early treatment of exercise-induced pulmonary hypertension with inhaled Treprostinil can improve pulmonary vascular hemodynamics, preserve cardiopulmonary reserve, and delay progression to overt resting pulmonary hypertension in patients with interstitial lung disease (ILD) or connective tissue disease (CTD).\n\nA. Objectives\n\nPrimary Objective:\n\n• To evaluate the effect of inhaled treprostinil on exercise pulmonary vascular resistance (PVR) at 6 months in patients with PH-ILD or PH-CTD exercise-induced pulmonary hypertension.\n\nSecondary Objectives:\n\n* To assess the effect of inhaled treprostinil on additional exercise hemodynamic parameters, including mPAP\u002FCO slope, right ventricular stroke work index (RVSWI), and pulmonary arterial compliance at 6 months.\n* To evaluate the effect of inhaled treprostinil on functional capacity measured by 6- minute walk distance at 6 months.\n* To assess the effect of inhaled treprostinil on exercise tolerance and dyspnea measured by the dyspnea (BORG) questionnaire at 6 months.\n* To evaluate the safety and tolerability of inhaled treprostinil in patients with exercise induced PH.\n* To assess the proportion of patients progressing to resting PH at 12 months (if the studyextends based on positive 6-month results).\n* To evaluate sustained hemodynamic and functional benefits at 12 months (if the study is extended).\n\nHypotheses \u002F Research Question(s) Treatment with inhaled treprostinil in patients with PH-ILD or PH-CTD with exercise-induced pulmonary hypertension will result in improvement in pulmonary vascular physiology and clinical outcomes. Specifically, inhaled treprostinil administered over 6 months is hypothesized to reduce exercise pulmonary vascular resistance (PVR), improve exercise hemodynamic parameters including mPAP\u002FCO slope, right ventricular stroke work index, and pulmonary arterial compliance, enhance functional capacity as measured by 6-minute walk distance, and improve exercise tolerance and dyspnea as assessed by BORG scores. Inhaled treprostinil is further hypothesized to be safe and well tolerated in this population and may reduce progression to resting pulmonary hypertension, with sustained hemodynamic and functional benefits observed at 12 months among patients continuing therapy\n\nResearch Procedures Screening: Resting RHC on all ILD and CTD patients to exclude resting PH.\n\nBaseline: Exercise RHC + iCPET to identify exercise PH and then select eligible patients. Once a matched pair is identified, one participant will be assigned to receive inhaled treprostinil and the other will receive standard of care. Assignment within each matched pair will be determined using a simple allocation method (such as alternating assignment) to reduce bias.\n\nTreatment Period: 6 months with monthly visits (or more if needed) with 6MWT, BNP, safety assessments.\n\nPrimary Endpoint: Month 6 exercise RHC + iCPET, functional and quality of life assessments.\n\nGo\u002FNo-Go Decision: Extend to 12 months if ≥ 1.0 WU reduction in peak VR, acceptable safety, ≥ 70% completion rate.",[56,62],{"label":57,"type":58,"description":59,"interventionNames":60},"Inhaled Treprostinil Plus Standard of Care","EXPERIMENTAL","Participants receive inhaled treprostinil (Tyvaso) in addition to standard disease-specific care.",[61],"Drug: Treprostinil",{"label":63,"type":64,"description":65,"interventionNames":66},"Standard of Care","ACTIVE_COMPARATOR","Participants receive standard disease-specific care without inhaled treprostinil",[67],"Other: Standard of Care",[69,74],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":46},"DRUG","Treprostinil","Description:\n\n* Initial dose 18 mcg four times daily\n* Titrated to 54-72 mcg four times daily as tolerated Standard disease-specific therapy continues",[57],{"type":6,"name":63,"description":75,"armGroupLabels":76,"otherNames":46},"Standard management of ILD\u002FCTD without treprostinil.",[63],[78],{"name":79,"affiliation":5,"role":80},"Ashish Rai Rai, MD","PRINCIPAL_INVESTIGATOR",[82,87],{"name":83,"role":84,"phone":85,"phoneExt":46,"email":86},"Ashish Rai, MD","CONTACT","201-447-8019","Raias@valleyhealth.com",{"name":88,"role":84,"phone":89,"phoneExt":46,"email":90},"Emma Goebel, APN","2014478019","nichem@Valleyhealth.com",[92,110],{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"The Valley Hospital","RECRUITING","Paramus","New Jersey","07652","United States","US",{"type":101,"coordinates":102},"Point",[103,104],-74.07542,40.94454,{"lat":104,"lon":103},[107,108,109],{"name":83,"role":84,"phone":85,"phoneExt":46,"email":86},{"name":88,"role":84,"phone":89,"phoneExt":46,"email":90},{"name":83,"role":80,"phone":46,"phoneExt":46,"email":46},{"facility":111,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":112,"geoPoint":114,"contacts":46},"Valley Medical Group Pulmonary Hypertension Clinic",{"type":101,"coordinates":113},[103,104],{"lat":104,"lon":103},{"type":116,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100657470","early-phase-1-early-intervention-with-inhaled-treprostinil-among-patients-with-exercise-induced-pulmonary-hypertension-epih-100657470",false,"NCT07837830","Early Intervention With Inhaled Treprostinil Among Patients With Exercise-Induced Pulmonary Hypertension (EPIH)","Early Intervention With Inhaled Treprostinil Among Patients With Exercise-Induced Pulmonary Hypertension: A Prospective Open-Label Matched Control Pilot Trial.","EPIH IIT","Inclusion Criteria:\n\n* Age ≥18 years\n* ILD diagnosis or CTD diagnosis\n* WHO Functional Class II-III\n* Resting RHC:\n\n  * mPAP ≤20 mmHg\n  * PVR ≤2 WU\n  * PAWP ≤15 mmHg\n* Exercise-induced pulmonary hypertension on iCPET\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Resting pulmonary hypertension\n* Significant left heart disease\n* CTEPH\n* Acute PE within 6 months\n* Current PAH-targeted therapy\n* Pregnancy or breastfeeding\n* Severe renal or hepatic impairment\n* Inability to perform exercise testing\n* Contraindication to RHC\n* Treprostinil hypersensitivity","ALL","18 Years",{"count":128,"type":129},32,"ESTIMATED","INTERVENTIONAL",[132],"EARLY_PHASE1","This prospective open-label matched-control pilot study evaluates whether inhaled treprostinil improves exercise pulmonary vascular resistance and functional outcomes in adults with interstitial lung disease or connective tissue disease and exercise-induced pulmonary hypertension. Participants will receive inhaled treprostinil plus standard care or standard care alone and will be followed for 6 months, with an optional extension to 12 months.",[135],"Pulmonary Hypertension",[135,71,137,138,139,140,141],"ILD","Pulmonary Vascular Resistance","Pulmonary Vascular Disease","iCPET","Connective Tissue Disease","2026-09-17",{"date":144,"type":145},"2026-09-24","ACTUAL",{"date":147,"type":129},"2026-09",{"date":149,"type":129},"2028-06",{"name":5,"class":6},2]