Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection (PHINDER)

May 26, 2026 updated by: United Therapeutics

Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection (PHINDER)

Study GMS-PH-001 is a multicenter, open-label, non-randomized study to prospectively evaluate screening strategies of pulmonary hypertension (PH) in patients with interstitial lung disease (ILD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, subjects will undergo a broad range of clinical assessments that are potentially associated with PH. Study data will be used to identify and weigh specific clinical parameters based on their prognostic significance for right heart catheterization (RHC)-confirmed PH. There is no study drug under investigation in this study. The study consists of 2 study visits: a Screening Visit and Study Visit 1.

Clinical assessments include pulmonary function tests (PFTs); high resolution computed tomography (HRCT); physical examination; 6-Minute Walk Test; blood draw for clinical laboratory parameters, plasma brain natriuretic peptide (BNP) concentration and plasma N-terminal pro-BNP (NT-proBNP) concentration; echocardiography; University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ); King's Brief Interstitial Lung Disease Questionnaire (K-BILD); 36-Item Short Form Survey (SF-36); Pulmonary Hypertension Functional Classification Self Report (PH-FC-SR); Investigator's Suspicion of PH Questionnaire; adverse event (AE) monitoring; and RHC.

As the primary objective of this study is to collect a broad range of clinical parameters in patients with ILD, it is expected that numerous exploratory and post-hoc analyses will be performed to identify and weigh specific parameters based on their prognostic significance for PH in this patient population with the goal of developing a screening algorithm for PH in patients with ILD.

Study Type

Observational

Enrollment (Actual)

314

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Pulmonary Associates
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford Hospital
    • Florida
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Health
      • Naples, Florida, United States, 34102
        • NCH Healthcare System
      • Tampa, Florida, United States, 33606
        • University of South Florida Health
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Austell, Georgia, United States, 30106
        • Piedmont Healthcare
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60153
        • Loyola University Chicago
      • Glenview, Illinois, United States, 60025
        • Northshore University Health System
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center New Orleans
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Int Med Pulmonary and Critical Care
      • Okemos, Michigan, United States, 48864
        • McLaren Greater Lansing
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Blessing Health Hannibal
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, United States, 27403
        • Pulmonix, LLC
      • Greenville, North Carolina, United States, 27834
        • East Carolina University
    • Oregon
      • Portland, Oregon, United States, 97210
        • Legacy Health
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health network
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Pulmonary and Sleep Medicine
      • Columbia, South Carolina, United States, 29203
        • Prisma Health
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • StatCare Pulmonary Consultants
    • Texas
      • Denison, Texas, United States, 75020
        • Premier Pulmonary Critical Care and Sleep Medicine
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center at San Antonio
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Healthcare
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Health
    • Vermont
      • Burlington, Vermont, United States, 05446
        • The University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23507
        • Sentara Cardiovascular Research Institute
      • Richmond, Virginia, United States, 23229
        • Pulmonary Associates of Richmond
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Medical Research Center
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Marshall Health
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with PH-ILD being treated in any setting, including academic, community, etc.

Description

Inclusion Criteria

  1. Patient gives voluntary written informed consent to participate in the study and are capable of reading and understanding questionnaires or forms in English or Spanish.

  2. Patients with a diagnosis of ILD based on computed tomography imaging, including:

    1. Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
    2. Connective tissue disease-associated ILD with forced vital capacity (FVC) <70%
    3. Hypersensitivity pneumonitis
    4. Scleroderma-related ILD
    5. Autoimmune ILD
    6. Nonspecific interstitial pneumonia
    7. Occupational lung disease
    8. Combined pulmonary fibrosis and emphysema with mild emphysema on lung imaging as determined by the Investigator
  3. Patients must have at least 2 signs or symptoms suggestive of PH, as specified by the study protocol.

Exclusion Criteria

  1. Prior RHC with mPAP >20 mmHg.
  2. Currently on a Food and Drug Administration (FDA)-approved pulmonary arterial hypertension (PAH) medication for the treatment of PAH.
  3. Diagnosed with chronic obstructive pulmonary disease (CPFE with mild emphysema notwithstanding).
  4. Uncontrolled or untreated moderate to severe sleep apnea as determined by the patient's physician.
  5. Pulmonary embolism within the past 3 months.
  6. History of ischemic heart disease or left-sided myocardial dysfunction within 12 months of Screening, defined as left ventricular ejection fraction <40% or pulmonary capillary wedge pressure >15 mmHg.
  7. Any other clinical features that, in the opinion of the Investigator, might adversely affect interpretation of study data or study safety, or make the patient unsuitable for RHC or HRCT (e.g., pregnancy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental study arm
All enrolled patients in this single arm study will receive a RHC.
Procedure: Right heart catheterization (RHC)
RHC to evaluate pulmonary hemodynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with PH as indicated by RHC
Time Frame: Through study completion, approximately 3 weeks.
Mean pulmonary artery pressure (mPAP) >20 mmHg with pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) >2 WU.
Through study completion, approximately 3 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with severe PH as indicated by RHC
Time Frame: Through study completion, approximately 3 weeks.
mPAP >20 mmHg with PAWP ≤15 mmHg and PVR >5 WU.
Through study completion, approximately 3 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Actual)

March 13, 2026

Study Completion (Actual)

April 29, 2026

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMS-PH-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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