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

Locations (1)

FacilityCityStateZIPSite coordinators
Temple University HospitalPhiladelphiaPennsylvania19140
Shameek Gayen, MD
267-990-3630

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