[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603495":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":92,"collaborators":96,"id":105,"slug":10,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":10,"eligibilityCriteria":109,"healthyVolunteers":106,"sex":110,"minAge":111,"maxAge":10,"enrollmentInfo":112,"targetDuration":10,"studyType":115,"phases":10,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Paracelsus Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients newly diagnosed with precapillary pulmonary hypertension",null,"Diagnosis of precapillary pulmonary hypertension confirmed by right heart catheterization (as described under inclusion criteria) with follow-up visits planned by the treating clinician in the next 3-12 months.",[13],"Device: Accelerometer (measurement of walking activity)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Accelerometer (measurement of walking activity)","Wearing an accelerometer (size 23x32,5x8,9 mm, weight 11g) on the lower back consistently for one week at a time to measure walking activity. The sensor is fixed with waterproof plasters. No feedback is given to the participant while wearing the sensor and no data can be read directly from the sensor.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Prof. Dr. med. Simon Jäger","CONTACT","+49 911-398-2822","simon.jaeger@klinikum-nuernberg.de",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Simone Panzer","+49 911-398-119943","simone.panzer@klinikum-nuernberg.de",[31,50,64,78],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Robert Bosch Hospital","RECRUITING","Stuttgart","Baden-Wurttemberg","70376","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],9.17702,48.78232,{"lat":43,"lon":42},[46],{"name":47,"role":23,"phone":48,"phoneExt":10,"email":49},"Dr. med. Alessandro Ghiani","0711-8101-7201","alessandro.ghiani@rbk.de",{"facility":51,"status":33,"city":52,"state":53,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic","Munich","Bavaria","81377",{"type":40,"coordinates":56},[57,58],11.57549,48.13743,{"lat":58,"lon":57},[61],{"name":62,"role":23,"phone":10,"phoneExt":10,"email":63},"Dr. med. Michaela Barnikel","michaela.barnikel@med.uni-muenchen.de",{"facility":65,"status":33,"city":66,"state":53,"zip":67,"country":37,"countryCode":38,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Klinikum Nuremberg","Nuremberg","90419",{"type":40,"coordinates":69},[70,71],11.07752,49.45421,{"lat":71,"lon":70},[74,75,76],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":27,"role":23,"phone":10,"phoneExt":10,"email":29},{"name":22,"role":77,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":79,"status":80,"city":81,"state":10,"zip":82,"country":37,"countryCode":38,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein","NOT_YET_RECRUITING","Löwenstein","74245",{"type":40,"coordinates":84},[85,86],9.38,49.09558,{"lat":86,"lon":85},[89],{"name":90,"role":23,"phone":10,"phoneExt":10,"email":91},"Dr. med. Stephan Beckmann","stephan.beckmann@slk-kliniken.de",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Simon Jäger","Head: Institute of Clinical Pharmacology",[97,99,101,103],{"name":98,"class":6},"Klinikum Nürnberg",{"name":100,"class":6},"LMU Klinikum",{"name":102,"class":6},"SLK Kliniken Heilbronn GmbH",{"name":104,"class":6},"Robert Bosch Medical Center","100603495",false,"NCT07137260","Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial","Inclusion Criteria:\n\n* Pulmonary hypertension confirmed by right heart catheterization\n* Presence of precapillary pulmonary hypertension at time of recruitment, defined as mean pulmonary arterial pressure (MAP) ≥ 20 mmHg, pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg and pulmonary vascular resistance (PVR) \\> 2 Wood units (160 dyn·s·cm-5)\n* After the right heart catheterization another follow-up visit is required in 3, 6, or 12 months\n* Independent walking without assistance and a 6-min walking distance \\> 100m\n* WHO Functional Class I-III\n* Ability to provide informed consent and to participate in the study procedures\n* Willingness to wear the Axivity AX6 Sensor for 7 days\n\nExclusion Criteria:\n\n* Hospitalization for a pulmonological disease within the 30 days prior to study recruitment\n* Neurological or orthopedic disease which limits walking ability\n* Acute pain which limits walking ability\n* Poor vision, which limits walking ability\n* Terminal illness with life expectancy \\\u003C 1 year\n* Ongoing treatment for malignancy\n* Acute psychosis or other severe psychiatric illness\n* Substance dependence","ALL","18 Years",{"count":113,"type":114},77,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to validate digital mobility outcomes for monitoring the treatment and disease progression in adult patients with pulmonary hypertension. The main question it aims to answer is:\n\n-Do digital mobility outcomes (measured digital endpoints characterizing walking behavior) correlate with measures of precapillary pulmonary pressure as assessed by right heart catheterization?\n\nParticipants will be asked to wear a small sensor on the lower back for one week at a time for a total of 3 times: at diagnosis and follow-up visits at 3-6 months and again at 6-12 months. Follow-up visits are scheduled by the treating clinician. At the end of the study participants can choose to receive feedback on the sensor measurements.",[118,119,120,121],"Pulmonary Hypertension","Precapillary Pulmonary Hypertension","Right Heart Catheterisation","Digital Mobility Outcomes",[123,124,125,126,127,128,129,130,131,132,133,134],"Digital mobility assessment","Right heart catheterization","Mobility assessment","Digital mobility outcome","Pulmonary hypertension","Pulmonary arterial hypertension","Sensor","Axivity sensor","Precapillary pulmonary hypertension","Walking assessment","Walking test","Physical activity","2025-08-15",{"date":137,"type":138},"2025-08-22","ACTUAL",{"date":140,"type":138},"2024-04-19",{"date":142,"type":114},"2027-04",{"name":94,"class":6},4]