Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection
NCT ID: NCT05776225
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-08-11
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Experimental study arm
All enrolled patients in this single arm study will receive a RHC.
Right heart catheterization (RHC)
RHC to evaluate pulmonary hemodynamics
Interventions
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Right heart catheterization (RHC)
RHC to evaluate pulmonary hemodynamics
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Central Contacts
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Facility Contacts
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Da-Wei Liao, MD
Role: primary
Raj Parikh, MD
Role: primary
James Brown, MD
Role: primary
David H Lindner, DO
Role: primary
Debabrata Bandyopadhyay, MD
Role: primary
David Zisman, MD
Role: primary
Srihari Veeraraghavan, MD
Role: primary
Amy H Case, MD
Role: primary
Renea Jablonski, MD
Role: primary
Bradford C Bemiss, MD
Role: primary
Ali Khan, MD
Role: primary
Jimmy S Smith, DO
Role: primary
Krishnan Amita, MD
Role: primary
Elizabeth Belloli, MD
Role: primary
Majid Mughal, MD
Role: primary
Humam Farah, MD
Role: primary
Farah Madhani-Lovely, MD
Role: primary
Jeffrey I Stewart, MD
Role: primary
Rany Condos, MD
Role: primary
Ali Mansour, MD
Role: primary
Aparna Swaminathan, MD
Role: primary
Matt Hunsucker, MD
Role: primary
Veeranna Maddipati, MD
Role: primary
David Sears, DO
Role: primary
Douglas S Corwin, MD
Role: primary
Abhijit A Raval, MD
Role: primary
Karla Cruz Morel, MD
Role: primary
Eric Weaver, MD
Role: primary
Sanober Kable, MD
Role: primary
Sandeep Sahay, MD
Role: primary
Rodolfo Estrada Anzueto, MD
Role: primary
Peter Crossno, MD
Role: primary
Emily Beck, MD
Role: primary
Jessica B Badlam, MD
Role: primary
Tessy Paul, MD
Role: primary
Steven Nathan, MD
Role: primary
Matthew Bernens, MD
Role: primary
Shilpa E Johri, MD
Role: primary
Amro K Al-Astal, MD
Role: primary
Mark Barash, MD
Role: primary
References
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Kulkarni T, Zisman DA, Shlobin OA, Kiely DG, DerSarkissian M, Shen E, Maher KM, Broderick M, Scholand MB. Study Design and Rationale for the PHINDER Study: Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection. Pulm Ther. 2025 Sep;11(3):491-501. doi: 10.1007/s41030-025-00307-0. Epub 2025 Jul 25.
Other Identifiers
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GMS-PH-001
Identifier Type: -
Identifier Source: org_study_id
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