Chronic Lung DiseaseNCT07151768
Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension
An observational study of Chronic Lung Disease and Pulmonary Hypertension, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Lung Disease, Pulmonary Hypertension
- What is being tested?
- Observational Study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Adult patients with chronic lung disease and pulmonary hypertension
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Shameek Gayen, MD, 267-990-3630, shameek.gayen@tuhs.temple.edu
About this study
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.
Read the detailed description
Objectives:
Primary objective: Prospectively validate the PVD-B65 risk score in patients newly diagnosed with or referred to our center with chronic lung disease and pulmonary hypertension by assigning a PVD-B65 score at time of diagnosis and/or referral and following one-year mortality outcome.
Secondary objectives:
- Assess whether the risk severity assigned from the PVD-B65 score in patients newly diagnosed with or referred to our center with chronic lung disease and pulmonary hypertension can predict clinical worsening.
- Assess whether optimal treatment in line with standard of care of both chronic lung disease and pulmonary hypertension can modify the initial risk severity assigned from the PVD-B65 score and in turn influence survival outcomes.
Primary endpoint: One-year outcome of mortality vs. lung transplantation vs. alive without lung transplantation
Secondary endpoints
- Composite endpoint of clinical worsening defined as hospitalization for respiratory failure, worsening oxygen requirement, intensification of pulmonary vasodilator therapy from initial treatment
- Change in PH markers (mPAP, PVR, cardiac output, cardiac index via RHC; PASP via TTE, pulmonary artery diameter and pulmonary artery to aorta ratio on CT chest)
- Change in lung function (FEV1, FVC), 6MWD, and DLCO
- Change in PVD-B65 score and associated risk severity through duration of study
- Conditions
- Chronic Lung Disease, Pulmonary Hypertension
- Being tested
- Observational Study
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyDiagnostic test
- assignment of PVD-B65 score derived from standard of care testing
- no therapeutic intervention or other treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of one year mortality
death (yes or no)
Measured: One year
Secondary outcomes (5)
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
Measured: one year
Change in PH severity via RHC
PVR in Woods units via RHC
Measured: Assessed every 6 months for one year
Change in PH severity via TTE
Estimated PASP in mmHg
Measured: Assessed every 3 months for one year
Change in functional status
6 minute walk distance in meters
Measured: Assessed every 3 months for one year
Change in PVD-B65 score and associated risk severity through duration of study
PVD-B65 risk score (absolute numeric value) calculated throughout study as described above
Measured: Every 3 months for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151768
- Sponsor's protocol ID
- 32278
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07151768
- Acronym / sponsor ID
- 32278
- Conditions
- Chronic Lung Disease, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
Primary objective: Prospectively validate the PVD-B65 risk score in patients newly diagnosed with or referred to our center with chronic lung disease and pulmonary hypertension by assigning a PVD-B65 score at time of diagnosis and/or referral and following one-year mortality outcome.
Secondary objectives:
- Assess whether the risk severity assigned from the PVD-B65 score in patients newly diagnosed with or referred to our center with chronic lung disease and pulmonary hypertension can predict clinical worsening.
- Assess whether optimal treatment in line with standard of care of both chronic lung disease and pulmonary hypertension can modify the initial risk severity assigned from the PVD-B65 score and in turn influence survival outcomes.
Primary endpoint: One-year outcome of mortality vs. lung transplantation vs. alive without lung transplantation
Secondary endpoints
- Composite endpoint of clinical worsening defined as hospitalization for respiratory failure, worsening oxygen requirement, intensification of pulmonary vasodilator therapy from initial treatment
- Change in PH markers (mPAP, PVR, cardiac output, cardiac index via RHC; PASP via TTE, pulmonary artery diameter and pulmonary artery to aorta ratio on CT chest)
- Change in lung function (FEV1, FVC), 6MWD, and DLCO
- Change in PVD-B65 score and associated risk severity through duration of study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic lung disease and pulmonary hypertension
Key inclusion criteria (6 listed)
- Eligibility criteria
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study* assignment of PVD-B65 score derived from standard of care testing * no therapeutic intervention or other treatment | Diagnostic test | – |
Primary outcome
Prediction of one year mortality
Time frame: One year
death (yes or no)
5 secondary outcomes
Clinical worsening
Time frame: one year
Change in PH severity via RHC
Time frame: Assessed every 6 months for one year
Change in PH severity via TTE
Time frame: Assessed every 3 months for one year
Change in functional status
Time frame: Assessed every 3 months for one year
Change in PVD-B65 score and associated risk severity through duration of study
Time frame: Every 3 months for one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lung Disease and Pulmonary Hypertension, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shameek Gayen, MD (267-990-3630, shameek.gayen@tuhs.temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of one year mortality (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.