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

Recruiting

• Conditions: Interstitial Lung Disease; Pulmonary Hypertension

• Registration Number: NCT05776225
• Lead Sponsor: United Therapeutics

Brief 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).

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 Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-20
• Study Start: 2023-08-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with PH as indicated by RHC	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with severe PH as indicated by RHC	Through study completion, approximately 3 weeks.	mPAP \>20 mmHg with PAWP ≤15 mmHg and PVR \>5 WU.

Trial Locations

Locations (42)

Renown Regional Medical Center; 🇺🇸 Reno, Nevada, United States

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

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