[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604611":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":36,"collaborators":7,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":7,"eligibilityCriteria":43,"healthyVolunteers":40,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":7,"studyType":50,"phases":7,"briefSummary":51,"conditions":52,"keywords":7,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},{"fullName":5,"class":6},"Temple University","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Observational Study","* assignment of PVD-B65 score derived from standard of care testing\n* no therapeutic intervention or other treatment",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Shameek Gayen, MD","CONTACT","267-990-3630","shameek.gayen@tuhs.temple.edu",[20],{"facility":21,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Temple University Hospital","RECRUITING","Philadelphia","Pennsylvania","19140","United States","US",{"type":29,"coordinates":30},"Point",[31,32],-75.16362,39.95238,{"lat":32,"lon":31},[35],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},{"type":37,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100604611","prospective-validation-of-the-novel-pvd-b65-risk-score-in-patients-with-chronic-lung-disease-and-pulmonary-hypertension-100604611",false,"NCT07151768","Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension","Inclusion Criteria:\n\n* Eligibility criteria\n\n  1. Adult patients ≥ 18 years of age with chronic lung disease diagnosed via CT chest and\u002For PFT data and pre-capillary pulmonary hypertension diagnosed via right-heart catheterization (RHC, mPAP \\> 20 mmHg, PVR \\> 2 WU, and PCWP ≤ 15 mmHg)\n\n     1. Chronic lung disease diagnoses will include: COPD, IPF, other pulmonary fibrosis, non-fibrotic ILD, combined pulmonary fibrosis and emphysema, and advanced pulmonary sarcoidosis with parenchymal involvement\n     2. PFT criteria will include an FEV1\u002FFVC \\\u003C 0.70 for the diagnosis of COPD\n  2. Willingness to make return visits and be available by telephone for the duration of the study.\n  3. Ability to participate in necessary testing, including ambulatory testing\n\nExclusion Criteria:\n\n* Exclusion criteria\n\n  1. Patients with pulmonary hypertension but without associated chronic lung disease (i.e. idiopathic or group 1 PAH, PH with post-capillary component defined as PCWP \\> 15 mmHg or group 2 PAH, CTEPH or group 4 PH, group 5 PH aside from sarcoidosis with parenchymal involvement)\n  2. Patients with uncontrolled severe systemic disease that could influence life expectancy (i.e. uncontrolled cardiovascular disease, active malignancy, etc.)\n  3. Prior lung and\u002For heart transplantation","ALL","18 Years","99 Years",{"count":48,"type":49},100,"ESTIMATED","OBSERVATIONAL","Prospective observational study to determine if the PVD-B65 risk score for one-year mortality in patients with chronic lung disease and pulmonary hypertension (CLD-PH) can accurately risk stratify these patients and successfully predict one-year mortality from time of pulmonary hypertension diagnosis. PVD-B65 risk score was developed in a retrospective cohort of patients with CLD-PH, utilizing the presence of pulmonary fibrosis without emphysema, pulmonary vascular resistance (PVR) \\> 5 woods units (WU), 6-minute walk distance (6MWD) \\\u003C 150 meters, B-natriuretic type peptide (BNP) \\> 200 pg\u002FmL or N-terminal pro-natriuretic type peptide (NT-proBNP) \\> 300 pg\u002FdL, and age \\> 65 years as the score components.",[53,54],"Chronic Lung Disease","Pulmonary Hypertension","2025-08-25",{"date":57,"type":58},"2025-09-03","ACTUAL",{"date":60,"type":49},"2025-09-01",{"date":62,"type":49},"2028-09-01",{"name":5,"class":6},1]