Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT07151768

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

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

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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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