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

ConditionsChronic Lung DiseasePulmonary 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

This trial does not accept healthy volunteers

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 population

Adult patients with chronic lung disease and pulmonary hypertension

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational Study

    Diagnostic test

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Prediction of one year mortality

death (yes or no)

Time frame
One year

Secondary outcomes

1

Clinical worsening

Composite endpoint defined as having had hospitalization for respiratory failure, worsening oxygen requirement in L/min, or intensification of pulmonary vasodilator therapy from initial treatment

Time frame
one year
2

Change in PH severity via RHC

PVR in Woods units via RHC

Time frame
Assessed every 6 months for one year
3

Change in PH severity via TTE

Estimated PASP in mmHg

Time frame
Assessed every 3 months for one year
4

Change in functional status

6 minute walk distance in meters

Time frame
Assessed every 3 months for one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Temple University

Lead sponsor

Source ClinicalTrials.gov
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