PVD-B65 risk score for predicting one-year outcomes in chronic lung disease with pulmonary hypertension

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

This study will test whether the PVD-B65 score can predict one-year death, lung transplant, or survival in adults with chronic lung disease and pulmonary hypertension.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Temple University (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT07151768 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort in which adults newly diagnosed with or referred for chronic lung disease–associated pre-capillary pulmonary hypertension will have a PVD-B65 score assigned at diagnosis or referral and then be followed for one year. The primary outcome is one-year status (death, lung transplantation, or alive without transplant), and secondary outcomes include clinical worsening, changes in hemodynamic and imaging markers, and changes in lung function and the PVD-B65 score over time. Data sources include right-heart catheterization, echocardiography, CT chest, pulmonary function tests, 6-minute walk distance, and BNP/NT-proBNP measurements. No investigational treatments are given; treatment follows standard of care and the study observes whether treatment modifies risk and outcomes.

Who should consider this trial

Good fit: Adults (≥18 years) with chronic lung disease and confirmed pre-capillary pulmonary hypertension by right-heart catheterization who can attend baseline and follow-up testing are ideal candidates.

Not a fit: Patients who have pulmonary hypertension without underlying chronic lung disease (for example group 1 PAH or post-capillary/group 2 PH) are unlikely to benefit from this score.

Why it matters

Potential benefit: If validated, the PVD-B65 score could help clinicians identify higher-risk patients for closer monitoring, earlier therapeutic changes, or transplant referral.

How similar studies have performed: The PVD-B65 score was developed from a retrospective cohort that suggested association with one-year mortality, but prospective validation in this population is novel.

Eligibility criteria

Inclusion Criteria:

* Eligibility criteria

  1. 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)

     1. 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
     2. PFT criteria will include an FEV1/FVC \< 0.70 for the diagnosis of COPD
  2. Willingness to make return visits and be available by telephone for the duration of the study.
  3. Ability to participate in necessary testing, including ambulatory testing

Exclusion Criteria:

* Exclusion criteria

  1. 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)
  2. Patients with uncontrolled severe systemic disease that could influence life expectancy (i.e. uncontrolled cardiovascular disease, active malignancy, etc.)
  3. Prior lung and/or heart transplantation

Where this trial is running

Philadelphia, Pennsylvania

• Temple University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Shameek Gayen, MD

Conditions Chronic Lung Disease; Pulmonary Hypertension