Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
View:

• Eligibility criteria

‣ Adult patients ≥ 18 years of age with chronic lung disease diagnosed via CT chest and/or PFT data and pre-capillary pulmonary hypertension diagnosed via right-heart catheterization (RHC, mPAP \> 20 mmHg, PVR \> 2 WU, and PCWP ≤ 15 mmHg)

• 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

∙ PFT criteria will include an FEV1/FVC \< 0.70 for the diagnosis of COPD

⁃ Willingness to make return visits and be available by telephone for the duration of the study.

⁃ Ability to participate in necessary testing, including ambulatory testing

Locations
United States
Pennsylvania
Temple University Hospital
RECRUITING
Philadelphia
Contact Information
Primary
Shameek Gayen, MD
shameek.gayen@tuhs.temple.edu
267-990-3630
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 100
Sponsors
Leads: Temple University

This content was sourced from clinicaltrials.gov