Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection
- Conditions
- Interstitial Lung DiseasePulmonary Hypertension
- Interventions
- Procedure: Right heart catheterization (RHC)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental study arm Right heart catheterization (RHC) All enrolled patients in this single arm study will receive a RHC.
- 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
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
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
NYU Langone Medical Center
🇺🇸New York, 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
St. Luke's University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
AnMed Health Pulmonary and Sleep Medicine
🇺🇸Anderson, South Carolina, United States
Prisma Health
🇺🇸Columbia, South Carolina, United States
StatCare Pulmonary Consultants
🇺🇸Knoxville, Tennessee, United States
Premier Pulmonary Critical Care and Sleep Medicine
🇺🇸Denison, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Intermountain Healthcare
🇺🇸Murray, Utah, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
The University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
Pulmonary Associates of Richmond
🇺🇸Richmond, Virginia, United States
Providence Medical Research Center
🇺🇸Spokane, Washington, United States
Marshall Health
🇺🇸Huntington, West Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States