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

NCT07151768 | Recruiting

• 1 other identifier: 32278
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Chronic Lung Disease; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Prediction of one year mortality

  death (yes or no)

  One year

Secondary Outcomes (5)

• Clinical worsening

  one year

• Change in PH severity via RHC

  Assessed every 6 months for one year

• Change in PH severity via TTE

  Assessed every 3 months for one year

• Change in functional status

  Assessed every 3 months for one year

• Change in PVD-B65 score and associated risk severity through duration of study

  Every 3 months for one year

Interventions

Observational Study DIAGNOSTIC_TEST

* assignment of PVD-B65 score derived from standard of care testing * no therapeutic intervention or other treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with chronic lung disease and pulmonary hypertension

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Shameek Gayen, MD

CONTACT

267-990-3630; shameek.gayen@tuhs.temple.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

US (1)