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

Last updated: May 26, 2026
Sponsor: United Therapeutics
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Vascular Diseases

Pulmonary Arterial Hypertension

Treatment

Right heart catheterization (RHC)

Clinical Study ID

NCT05776225
GMS-PH-001
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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:

  3. Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis

  4. Connective tissue disease-associated ILD with forced vital capacity (FVC) <70%

  5. Hypersensitivity pneumonitis

  6. Scleroderma-related ILD

  7. Autoimmune ILD

  8. Nonspecific interstitial pneumonia

  9. Occupational lung disease

  10. Combined pulmonary fibrosis and emphysema with mild emphysema on lung imaging as determined by the Investigator

  11. 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 Design

Total Participants: 314
Treatment Group(s): 1
Primary Treatment: Right heart catheterization (RHC)
Phase:
Study Start date:
August 11, 2023
Estimated Completion Date:
April 29, 2026

Study 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.

Connect with a study center

  • Pulmonary Associates

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Pulmonary Associates

    Phoenix 5308655, Arizona 5551752 85032
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Hartford Hospital

    Hartford 4835797, Connecticut 4831725 06106
    United States

    Site Not Available

  • Lakeland Regional Health

    Lakeland, Florida 33805
    United States

    Site Not Available

  • NCH Healthcare System

    Naples, Florida 34102
    United States

    Site Not Available

  • University of South Florida Health

    Tampa, Florida 33606
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Lakeland Regional Health

    Lakeland 4161438, Florida 4155751 33805
    United States

    Site Not Available

  • NCH Healthcare System

    Naples 4165565, Florida 4155751 34102
    United States

    Site Not Available

  • University of South Florida Health

    Tampa 4174757, Florida 4155751 33606
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston 4178003, Florida 4155751 33331
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Piedmont Healthcare

    Austell, Georgia 30106
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Piedmont Healthcare

    Austell 4180564, Georgia 4197000 30106
    United States

    Site Not Available

  • Loyola University Chicago

    Chicago, Illinois 60153
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • NorthShore University Health System

    Glenview, Illinois 60025
    United States

    Site Not Available

  • Loyola University Chicago

    Chicago 4887398, Illinois 4896861 60153
    United States

    Site Not Available

  • Northwestern University

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • NorthShore University Health System

    Glenview 4893886, Illinois 4896861 60025
    United States

    Site Not Available

  • University of Kentucky Medical Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky Medical Center

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Site Not Available

  • LSU Health Sciences Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • LSU Health Sciences Center New Orleans

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Site Not Available

  • University of Michigan Int Med Pulmonary and Critical Care

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Mclaren Greater Lansing

    Okemos, Michigan 48864
    United States

    Site Not Available

  • University of Michigan Int Med Pulmonary and Critical Care

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Mclaren Greater Lansing

    Okemos 5004359, Michigan 5001836 48864
    United States

    Site Not Available

  • Blessing Health Hannibal

    Hannibal, Missouri 63401
    United States

    Site Not Available

  • Blessing Health Hannibal

    Hannibal 4389418, Missouri 4398678 63401
    United States

    Site Not Available

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Site Not Available

  • Renown Regional Medical Center

    Reno 5511077, Nevada 5509151 89502
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune City, New Jersey 07753
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10467
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10467
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Pulmonix, LLC

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Duke University Medical Center

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Pulmonix, LLC

    Greensboro 4469146, North Carolina 4482348 27403
    United States

    Site Not Available

  • East Carolina University

    Greenville 4469160, North Carolina 4482348 27834
    United States

    Site Not Available

  • Legacy Health

    Portland, Oregon 97210
    United States

    Site Not Available

  • Legacy Health

    Portland 5746545, Oregon 5744337 97210
    United States

    Site Not Available

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • St. Luke's University Health Network

    Bethlehem 5180225, Pennsylvania 6254927 18015
    United States

    Site Not Available

  • AnMed Health Pulmonary and Sleep Medicine

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Prisma Health

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • AnMed Health Pulmonary and Sleep Medicine

    Anderson 4569298, South Carolina 4597040 29621
    United States

    Site Not Available

  • Prisma Health

    Columbia 4575352, South Carolina 4597040 29203
    United States

    Site Not Available

  • StatCare Pulmonary Consultants

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • StatCare Pulmonary Consultants

    Knoxville 4634946, Tennessee 4662168 37909
    United States

    Site Not Available

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison, Texas 75020
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Premier Pulmonary Critical Care and Sleep Medicine

    Denison 4685892, Texas 4736286 75020
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • The University of Texas Health Science Center at San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Intermountain Healthcare

    Murray, Utah 84107
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Intermountain Healthcare

    Murray 5778755, Utah 5549030 84107
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City 5780993, Utah 5549030 84108
    United States

    Site Not Available

  • The University of Vermont Medical Center

    Burlington, Vermont 05446
    United States

    Site Not Available

  • The University of Vermont Medical Center

    Burlington 5234372, Vermont 5242283 05446
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Pulmonary Associates of Richmond

    Richmond, Virginia 23229
    United States

    Site Not Available

  • University of Virginia

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Site Not Available

  • Sentara Cardiovascular Research Institute

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Site Not Available

  • Pulmonary Associates of Richmond

    Richmond 4781708, Virginia 6254928 23229
    United States

    Site Not Available

  • Providence Medical Research Center

    Spokane, Washington 99204
    United States

    Site Not Available

  • Providence Medical Research Center

    Spokane 5811696, Washington 5815135 99204
    United States

    Site Not Available

  • Marshall Health

    Huntington, West Virginia 25701
    United States

    Site Not Available

  • Marshall Health

    Huntington 4809537, West Virginia 4826850 25701
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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