Interstitial Lung DiseasePHINDERNCT05776225
Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection
An observational study of Interstitial Lung Disease and Pulmonary Hypertension, run by United Therapeutics at 42 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Pulmonary Hypertension
- What is being tested?
- Right heart catheterization (RHC)
- Type of treatment
- Surgery or procedure
- How many people
- 314 participants
- Where
- 42 sitesUnited States
- Study dates
- 11 Aug 2023to 29 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PH-ILD being treated in any setting, including academic, community, etc.
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, 29621
University of Michigan Int Med Pulmonary and Critical Care
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
Piedmont Healthcare
Austell, Georgia, 30106
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
The University of Vermont Medical Center
Burlington, Vermont, 05446
University of Virginia
Charlottesville, Virginia, 22903
Loyola University Chicago
Chicago, Illinois, 60153
Northwestern University
Chicago, Illinois, 60611
Prisma Health
Columbia, South Carolina, 29203
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
NorthShore University Health System
Glenview, Illinois, 60025
Pulmonix, LLC
Greensboro, North Carolina, 27403
East Carolina University
Greenville, North Carolina, 27834
Blessing Health Hannibal
Hannibal, Missouri, 63401
Hartford Hospital
Hartford, Connecticut, 06106
Houston Methodist Hospital
Houston, Texas, 77030
Marshall Health
Huntington, West Virginia, 25701
StatCare Pulmonary Consultants
Knoxville, Tennessee, 37909
Lakeland Regional Health
Lakeland, Florida, 33805
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Intermountain Healthcare
Murray, Utah, 84107
NCH Healthcare System
Naples, Florida, 34102
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
LSU Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
NYU Langone Medical Center
New York, New York, 10016
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Mclaren Greater Lansing
Okemos, Michigan, 48864
Pulmonary Associates
Phoenix, Arizona, 85032
Legacy Health
Portland, Oregon, 97210
Renown Regional Medical Center
Reno, Nevada, 89502
Pulmonary Associates of Richmond
Richmond, Virginia, 23229
University of Utah Health
Salt Lake City, Utah, 84108
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Providence Medical Research Center
Spokane, Washington, 99204
University of South Florida Health
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection (PHINDER)
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).
Read the 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.
- Conditions
- Interstitial Lung Disease, Pulmonary Hypertension
- Being tested
- Right heart catheterization (RHC)
- Keywords
- ILD, PH, PH-ILD
- Medical subject headings
- Lung Diseases, Interstitial, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right heart catheterization (RHC)Procedure or surgery
RHC to evaluate pulmonary hemodynamics
| Study group | Role | What they receive |
|---|---|---|
| Experimental study arm | All enrolled patients in this single arm study will receive a RHC. Receives: Procedure: Right heart catheterization (RHC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, approximately 3 weeks.
Secondary outcomes (1)
Percentage of patients with severe PH as indicated by RHC
mPAP >20 mmHg with PAWP ≤15 mmHg and PVR >5 WU.
Measured: Through study completion, approximately 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start11 Aug 2023
- Primary completion13 Mar 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776225
- Sponsor's protocol ID
- GMS-PH-001
- Acronym
- PHINDER
- Status last verified
- May 2026
- First submitted
- 1 Mar 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 May;43(5):2071-2089. doi: 10.1007/s12325-026-03508-4. Epub 2026 Mar 10.
PubMed 41806275Kulkarni 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.
PubMed 40711711
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection (PHINDER)
- ClinicalTrials.gov ID
- NCT05776225
- Acronym / sponsor ID
- PHINDER / GMS-PH-001
- Conditions
- Interstitial Lung Disease, Pulmonary Hypertension
- Keywords
- ILD, PH, PH-ILD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental study arm | – | Procedure: Right heart catheterization (RHC)All enrolled patients in this single arm study will receive a RHC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PH-ILD being treated in any setting, including academic, community, etc.
Key inclusion criteria (11 listed)
- 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:
- Patients must have at least 2 signs or symptoms suggestive of PH, as specified by the study protocol.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right heart catheterization (RHC)RHC to evaluate pulmonary hemodynamics | Procedure or surgery | Experimental study arm |
Primary outcome
Percentage of patients with PH as indicated by RHC
Time frame: 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.
1 secondary outcome
Percentage of patients with severe PH as indicated by RHC
Time frame: Through study completion, approximately 3 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 41806275Zisman 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 May;43(5):2071-2089. doi: 10.1007/s12325-026-03508-4. Epub 2026 Mar 10.
- Derived from this study: PubMed 40711711Kulkarni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Pulmonary Hypertension, run by United Therapeutics at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with PH as indicated by RHC (time frame: Through study completion, approximately 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05776225, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.