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
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Adults aged 18 to 99 years with chronic lung disease diagnosed by CT chest and/or pulmonary function tests
- Chronic lung diseases include COPD, idiopathic pulmonary fibrosis, other pulmonary fibrosis, non-fibrotic interstitial lung disease, combined pulmonary fibrosis and emphysema, or advanced pulmonary sarcoidosis with parenchymal involvement
- Pre-capillary pulmonary hypertension confirmed by right-heart catheterization with mPAP > 20 mmHg, PVR > 2 WU, and PCWP ≤ 15 mmHg
- COPD diagnosis includes FEV1/FVC ratio less than 0.70
- Willingness to attend return visits and be reachable by telephone for the study duration
- Ability to participate in necessary testing including ambulatory tests
You will not qualify if you...
- Pulmonary hypertension without associated chronic lung disease, such as idiopathic or group 1 PAH, group 2 PAH with post-capillary component (PCWP > 15 mmHg), chronic thromboembolic pulmonary hypertension (group 4), or group 5 PH except sarcoidosis with parenchymal involvement
- Uncontrolled severe systemic diseases that may affect life expectancy, including uncontrolled cardiovascular disease or active malignancy
- Prior lung or heart transplantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
Research Team
S
Shameek Gayen, MD
CONTACT
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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