Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Temple University
- Study ID
- NCT07151768
- Status
- Recruiting
Conditions
- Chronic Lung Disease
- Pulmonary Hypertension
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Observational Study — DIAGNOSTIC_TEST* assignment of PVD-B65 score derived from standard of care testing * no therapeutic intervention or other treatment
Study Details
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) \< 150 meters, B-natriuretic type peptide (BNP) \> 200 pg/mL or N-terminal pro-natriuretic type peptide (NT-proBNP) \> 300 pg/dL, and age \> 65 years as the score components.
Key Dates
- Start date
- Sep 1, 2025
- Status verified
- Aug 2025
- Primary completion
- Aug 31, 2028
- Completion
- Sep 1, 2028
Study Design
- Enrollment
- 100 participants (estimated)
Primary Outcome Measure
Prediction of one year mortality [ Time Frame: One year ]
Central Contacts
- Shameek Gayen, MD267-990-3630
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 |
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