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

Completed

Conditions studied: Interstitial Lung Disease, Pulmonary Hypertension

In brief

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).

Key facts

Study ID

NCT05776225

Run by

United Therapeutics

People needed

314

Starts

2023-08-11

Expected to finish

2026-04-29

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Prior RHC with mPAP >20 mmHg.
• Currently on a Food and Drug Administration (FDA)-approved pulmonary arterial hypertension (PAH) medication for the treatment of PAH.
• Diagnosed with chronic obstructive pulmonary disease (CPFE with mild emphysema notwithstanding).
• Uncontrolled or untreated moderate to severe sleep apnea as determined by the patient's physician.
• Pulmonary embolism within the past 3 months.
• 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.
• 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).

Where it is running

• Pulmonary Associates — Phoenix, Arizona, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Lakeland Regional Health — Lakeland, Florida, United States
• NCH Healthcare System — Naples, Florida, United States
• University of South Florida Health — Tampa, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Piedmont Healthcare — Austell, Georgia, United States
• Loyola University Chicago — Chicago, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• NorthShore University Health System — Glenview, Illinois, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• LSU Health Sciences Center New Orleans — New Orleans, Louisiana, United States
• University of Michigan Int Med Pulmonary and Critical Care — Ann Arbor, Michigan, United States
• Mclaren Greater Lansing — Okemos, Michigan, United States
• Blessing Health Hannibal — Hannibal, Missouri, United States
• Renown Regional Medical Center — Reno, Nevada, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• NYU Langone Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Pulmonix, LLC — Greensboro, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• Legacy Health — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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