NCT07151768 Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension
| NCT ID | NCT07151768 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Temple University |
| Condition | Chronic Lung Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-09-01 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07151768 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Chronic Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07151768 currently recruiting?
Yes, NCT07151768 is actively recruiting participants. Contact the research team at shameek.gayen@tuhs.temple.edu for enrollment information.
Where is the NCT07151768 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07151768 clinical trial?
NCT07151768 is sponsored by Temple University. The trial plans to enroll 100 participants.