Status:
RECRUITING
Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension
Lead Sponsor:
Temple University
Conditions:
Chronic Lung Disease
Pulmonary Hypertension
Eligibility:
All Genders
18-99 years
Brief 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 the...
Detailed Description
Objectives: Primary objective: Prospectively validate the PVD-B65 risk score in patients newly diagnosed with or referred to our center with chronic lung disease and pulmonary hypertension by assigni...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Exclusion criteria
- Patients with pulmonary hypertension but without associated chronic lung disease (i.e. idiopathic or group 1 PAH, PH with post-capillary component defined as PCWP \> 15 mmHg or group 2 PAH, CTEPH or group 4 PH, group 5 PH aside from sarcoidosis with parenchymal involvement)
- Patients with uncontrolled severe systemic disease that could influence life expectancy (i.e. uncontrolled cardiovascular disease, active malignancy, etc.)
- Prior lung and/or heart transplantation
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07151768
Start Date
September 1 2025
End Date
September 1 2028
Last Update
September 3 2025
Active Locations (1)
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1
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140