Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection
PHINDER
1 other identifier
observational
300
1 country
42
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Typical duration for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
August 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedMay 1, 2026
April 1, 2026
2.6 years
March 1, 2023
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with PH as indicated by RHC
Mean pulmonary artery pressure (mPAP) \>20 mmHg with pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) \>2 WU.
Through study completion, approximately 3 weeks.
Secondary Outcomes (1)
Percentage of patients with severe PH as indicated by RHC
Through study completion, approximately 3 weeks.
Study Arms (1)
Experimental study arm
All enrolled patients in this single arm study will receive a RHC.
Interventions
RHC to evaluate pulmonary hemodynamics
Eligibility Criteria
Patients with PH-ILD being treated in any setting, including academic, community, etc.
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Pulmonary Associates
Phoenix, Arizona, 85032, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Lakeland Regional Health
Lakeland, Florida, 33805, United States
NCH Healthcare System
Naples, Florida, 34102, United States
University of South Florida Health
Tampa, Florida, 33606, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Piedmont Healthcare
Austell, Georgia, 30106, United States
Loyola University Chicago
Chicago, Illinois, 60153, United States
Northwestern University
Chicago, Illinois, 60611, United States
NorthShore University Health System
Glenview, Illinois, 60025, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
LSU Health Sciences Center New Orleans
New Orleans, Louisiana, 70112, United States
University of Michigan Int Med Pulmonary and Critical Care
Ann Arbor, Michigan, 48109, United States
Mclaren Greater Lansing
Okemos, Michigan, 48864, United States
Blessing Health Hannibal
Hannibal, Missouri, 63401, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Pulmonix, LLC
Greensboro, North Carolina, 27403, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Legacy Health
Portland, Oregon, 97210, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, 29621, United States
Prisma Health
Columbia, South Carolina, 29203, United States
StatCare Pulmonary Consultants
Knoxville, Tennessee, 37909, United States
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Intermountain Healthcare
Murray, Utah, 84107, United States
University of Utah Health
Salt Lake City, Utah, 84108, United States
The University of Vermont Medical Center
Burlington, Vermont, 05446, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
Pulmonary Associates of Richmond
Richmond, Virginia, 23229, United States
Providence Medical Research Center
Spokane, Washington, 99204, United States
Marshall Health
Huntington, West Virginia, 25701, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (2)
Zisman D, Sahay S, Bandyopadhyay D, Al-Astal A, Broderick M, Caudell Stamper D, Champion H, DerSarkissian M, Hunsucker M, Lee D, Maher K, Nelsen A, Parikh R, Rahaghi F, Raval A, Thrasher CM, Kulkarni T, Shlobin OA, Kiely DG, Nathan S, Scholand MB. Screening for Pulmonary Hypertension in Interstitial Lung Disease: Preliminary Results from the PHINDER Study. Adv Ther. 2026 Mar 10. doi: 10.1007/s12325-026-03508-4. Online ahead of print.
PMID: 41806275DERIVEDKulkarni 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.
PMID: 40711711DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2023
First Posted
March 20, 2023
Study Start
August 11, 2023
Primary Completion
March 13, 2026
Study Completion
April 1, 2026
Last Updated
May 1, 2026
Record last verified: 2026-04