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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Temple University Hospital
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Shameek Gayen, MD
• Email: shameek.gayen@tuhs.temple.edu
• Phone: 267-990-3630

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.