Actively Recruiting
Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension
Led by Temple University · Updated on 2025-09-03
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the PVD-B65 risk score to predict one-year mortality in adults with chronic lung disease and pulmonary hypertension (CLD-PH). This prospective observational study aims to validate the score, which uses factors like pulmonary fibrosis, pulmonary vascular resistance, walking distance, peptide levels, and age to classify risk. The study also explores how the score predicts clinical worsening and whether standard treatments affect survival. Participants will have their PVD-B65 score assigned based on standard diagnostic testing at diagnosis or referral. There is no experimental treatment; the study only observes patients following usual care. The study will track health changes including pulmonary hypertension severity and lung function through tests like right-heart catheterization, echocardiograms, and lung function tests over one year. During the study, participants will be followed for one year with assessments every 3 to 6 months to monitor mortality, clinical worsening, and changes in risk score and lung health. Outcomes include survival status, hospitalizations, oxygen needs, therapy changes, and lung and heart function. The study team will collect data from routine care and tests to understand how well the PVD-B65 score predicts outcomes in these patients.
CONDITIONS
Brief Title
Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years or older with chronic lung disease diagnosed via chest CT or pulmonary function tests
- Pre-capillary pulmonary hypertension confirmed by right-heart catheterization (mPAP > 20 mmHg, PVR > 2 WU, PCWP ≤ 15 mmHg)
- Chronic lung diseases include COPD, idiopathic pulmonary fibrosis, other pulmonary fibrosis, non-fibrotic interstitial lung disease, combined pulmonary fibrosis and emphysema, and advanced pulmonary sarcoidosis with parenchymal involvement
- Willingness to return for follow-up visits and be available by phone during the study
- Ability to participate in testing including ambulatory assessments
You will not qualify if you...
- Pulmonary hypertension without associated chronic lung disease (such as idiopathic or group 1 PAH, post-capillary PH, chronic thromboembolic PH, or group 5 PH except sarcoidosis with parenchymal involvement)
- Uncontrolled severe systemic diseases that may affect life expectancy (e.g., uncontrolled cardiovascular disease, active cancer)
- Prior lung or heart transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At time of diagnosis and/or referral
Participants undergo assignment of the PVD-B65 risk score based on standard of care testing including chest CT, pulmonary function tests, right-heart catheterization, echocardiography, and other diagnostic assessments.
1 baseline visit (in-person)
Duration - 1 year
Participants are followed for one year with periodic assessments to monitor pulmonary hypertension severity, lung function, clinical status, and changes in PVD-B65 risk score.
Visits every 3 months with additional assessments every 6 months
Trial Site Locations
Total: 1 location
1
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
Research Team
S
Shameek Gayen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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