[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100422224":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":38,"centralContacts":42,"locations":49,"responsibleParty":70,"collaborators":47,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":47,"enrollmentInfo":84,"targetDuration":47,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Duke University","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"PAH:","EXPERIMENTAL","Clinical diagnosis of PAH (Group 1 PH) in the absence of severe chronic lung disease, left heart disease, chronic thromboembolism, sarcoidosis, sickle cell disease or other causes of non-Group 1 PH.",[13],"Drug: Hyperpolarized 129Xe",{"label":15,"type":10,"description":16,"interventionNames":17},"COPD-noPH","Clinical diagnosis of COPD in the absence of precapillary PH.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"COPD-PH","Clinical diagnosis of COPD with precapillary PH",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"IPF-noPH","Clinical diagnosis of IPF in the absence of precapillary PH",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"IPF-PH","Clinical diagnosis of IPF with precapillary PH",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Hyperpolarized 129Xe","Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),",[19,15,27,23,9],[37],"Xe MRI",[39],{"name":40,"affiliation":5,"role":41},"Sudarshan Rajagopal, MD, PhD","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Claudia Salazar","CONTACT","+1 919 660 2026",null,"claudia.salazar@duke.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Duke University Medical Center","RECRUITING","Durham","North Carolina","27710","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-78.89862,35.99403,{"lat":62,"lon":61},[65,69],{"name":66,"role":45,"phone":67,"phoneExt":47,"email":68},"David Ptashnik, MS","919-668-2642","david.ptashnik@duke.edu",{"name":40,"role":41,"phone":47,"phoneExt":47,"email":47},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"SPONSOR_INVESTIGATOR","Bastiaan Driehuys","Associate Professor of Radiology","100422224","phase-2-pulmonary-hypertension-solar-100422224",false,"NCT04778046","Pulmonary Hypertension SOLAR","Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH","PH SOLAR","Inclusion Criteria:\n\n1. Age ≥ 18 years' old\n2. Be on the lung transplant waiting list at Duke University Medical Center.\n3. PH as defined by RHC - mPAP \\> 20 mmHg, PVR \\> 3 WU, PCWP \\\u003C 15 mmHg\n4. Groups defined as:\n\n   PAH: Clinical diagnosis of PAH (Group 1 PH) in the absence of severe chronic lung disease, left heart disease, chronic thromboembolism, sarcoidosis, sickle cell disease, or other causes of non-Group 1 PH.\n\n   COPD-noPH: Clinical diagnosis of COPD in the absence of precapillary PH.\n\n   COPD-PH: Clinical diagnosis of COPD with precapillary PH.\n\n   IPF-noPH: Clinical diagnosis of IPF in the absence of precapillary PH.\n\n   IPF-PH: Clinical diagnosis of IPF with precapillary PH.\n5. Willing and able to give informed consent and adhere to visit\u002Fprotocol schedules (consent must be given before any study procedures are performed).\n\nExclusion Criteria:\n\n1. Moderate to severe heart disease (LVEF \\\u003C 45% or severe LV Hypertrophy).\n2. Sarcoidosis.\n3. Active cancer.\n4. Sickle cell anemia.\n5. Liver disease (Childs-Pugh class C).\n6. Prisoners and pregnant women will not be approached for the study.\n7. Inability to obtain consent.\n8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).\n9. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements","ALL","18 Years",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","The main goal of this study is to develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. PAH's unique 129Xe MRI signature has been shown in previous studies. Past studies have lacked a pathologic \"ground truth\" correlate of these signatures, which could be provided by comparing them with the pathology of lung explant tissue from patients who have undergone a lung transplant. This signature could be validated in a cohort of patients with Group 3 PH in future studies.",[92,93,94],"Interstitial Lung Disease","COPD","Pulmonary Arterial Hypertension",[96,97],"Lung Transplant","Group 3 PH","2026-02-23",{"date":100,"type":101},"2026-02-24","ACTUAL",{"date":103,"type":101},"2023-11-08",{"date":105,"type":86},"2028-07-31",{"name":72,"class":6},1]