[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588441":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":19,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":19,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University of Washington","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise Arm","EXPERIMENTAL","Patients with PAH on sotatercept plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring",[13],"Other: Home exercise program",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Home exercise program","A tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Mary Beth Brown, PT, PhD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Claire E Child, DPT, MPH","CONTACT","206-616-8601","cechild@uw.edu",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Seattle","Washington","98195","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-122.33207,47.60621,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":46},"pah-study@uw.edu",{"type":23,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Mary Beth Brown","Associate Professor, Department of Rehabilitation Medicine","100588441","phase-3-pah-exercise-study-100588441",false,"NCT06941441","PAH Exercise Study","Remotely-Monitored Exercise to Enhance Functional Outcomes in Patients With Pulmonary Arterial Hypertension (PAH) Initiating Sotatercept Therapy: A Single-site Feasibility Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug\u002Ftoxin-induced PAH, PAH associated with CTD, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair\n* Symptomatic PH classified as WHO FC II or III\n* Baseline RHC performed during the Screening Period documenting a minimum PVR of ≥ 5 WU and a pulmonary capillary wedge (PCWP) or left ventricular end-diastolic pressure of ≤ 15 mmHg\n* Receiving stable background therapy for PAH for \\>90 days and will continue receiving throughout trial. Background treatments may consist of monotherapy, double therapy, or triple therapy with currently available medications for PAH.\n* Initiation of Sotatercept is clinically indicated\n* Willing and able to participate in a remotely-monitored home exercise program for 24 weeks\n* Ability to adhere to study visit schedule and understand and comply with all protocol requirements\n* Ability to understand and provide written informed consent\n\nExclusion Criteria:\n\n* Diagnosis of PH WHO Groups 2, 3, 4, or 5\n* Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease\n* Hemoglobin at screening above gender-specific ULN\n* Baseline platelet count \\\u003C 50,000\u002Fmm3 (\\\u003C 50.0 × 109\u002FL) at screening\n* Uncontrolled systemic hypertension as evidenced by sitting systolic BP \\> 160 mmHg or sitting diastolic BP \\> 100 mmHg during screening visit after a period of rest; Baseline systolic BP \\\u003C 90 mmHg at screening\n* Pregnant or breastfeeding females\n* Clinical laboratory liver and kidney function tests outside of normal range\n* Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent\n* Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536) or known allergic reaction to either one\n* History of full pneumonectomy\n* Initiation of a structured exercise program within 90 days prior or planned initiation during the study\n* Known history of portal hypertension or chronic liver disease, including hepatitis B and\u002For hepatitis C (with evidence of recent infection and\u002For active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C).\n* Cardiac related history: History of restrictive, constrictive, or congestive cardiomyopathy; History of atrial septostomy within 180 days prior to the screening visit; ECG with Fridericia's corrected QT interval (QTcF) \\> 500 ms during the Screening Period; Personal or family history of long QT syndrome (LQTS) or sudden cardiac death; Left ventricular ejection fraction (LVEF) \\\u003C 45% on historical ECHO within 12 months prior to the screening visit; Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions\n* Cerebrovascular accident within 3 months prior to the screening visit\n* Acutely decompensated heart failure within 14 days prior to the screening visit, as per investigator assessment\n* Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease\n* Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit","ALL","18 Years",{"count":60,"type":61},10,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","Ten patients with PAH who are stable and eligible to initiate sotatercept therapy will participate in a 26 week study that consists of a 24-week intervention period where patients will receive complimentary sotatercept as prescribed, plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring.",[67,68],"Pulmonary Arterial Hypertension (PAH)","Exercise Therapy",[70,71,72,73],"PAH","pulmonary arterial hypertension","sotatercept","exercise","2025-04-15",{"date":76,"type":77},"2025-04-23","ACTUAL",{"date":74,"type":77},{"date":80,"type":61},"2026-09-30",{"name":5,"class":6},1]