Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorTemple University
About this trial
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
Qualifiers
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
Disqualifiers
Exclusion criteria
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
Trial design
Treatments tested in this trial
- Observational Study
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov