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Pulmonary Hypertension Due to Lung Diseases and HypoxiaNCT06388421

DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

An observational study of Pulmonary Hypertension Due to Lung Diseases and Hypoxia and Pulmonary Hypertension, run by United Therapeutics at 71 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, real world, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and interstitial lung disease (ILD). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prospective study assessments
How many people
900 participants
Where
71 sitesin 2 countries
Study dates
23 Jan 2025to 30 Nov 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 a diagnosis of pulmonary hypertension associated with interstitial lung disease or interstitial lung disease. This includes patients who are and aren't receiving inhaled treprostinil, excluding patients receiving Yutrepia™ at Baseline.

Who may be able to join

  • Adults aged 18 years or older
  • Diagnosis of fibrotic ILD based on high-resolution computed tomography imaging, including but not limited to:
  • Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
  • Autoimmune ILD
  • Chronic hypersensitivity pneumonitis
  • Nonspecific interstitial pneumonia
Show all 15Show fewer
  • Occupational lung disease
  • Combined pulmonary fibrosis and emphysema with fibrosis greater than the extent of emphysema on lung imaging as determined by the Investigator
  • For patients to be eligible for Cohorts 1 to 3: RHC confirmed PH (mean pulmonary artery pressure >20 mmHg, pulmonary artery wedge pressure
  • ≤15 mmHg, pulmonary vascular resistance >2 WU).
  • For patients to be eligible for Cohort 1, they must not be receiving inhaled treprostinil at Baseline.
  • For patients to be eligible for Cohort 2, they must have initiated
  • Tyvaso/Tyvaso DPI at 1 of the following time points:
  • Baseline
  • ≤90 days prior to Baseline 6. For patients to be eligible for Cohort 3, they must be receiving Tyvaso/Tyvaso DPI at Baseline and for >90 days prior to Baseline. 7. For patients to be eligible for Cohort 4: Prior RHC not meeting the definition of PH as described in Inclusion Criterion 3 but has a pulmonary artery wedge pressure ≤15 mmHg. 8. Co-enrollment in other observational or interventional studies is permitted. 9. Patient is willing and able to provide informed consent and complete surveys/questionnaires in English or Spanish.

Who cannot join

  • Confirmed diagnosis of Group 1, 2, 4, or 5 PH
  • In cases in which a patient has a diagnosis of PH-ILD along with a concomitant diagnosis of another PH group (eg, Group 1), enrollment may be permitted at the Investigator's discretion if, in their clinical judgment, PH-ILD is the predominant driver of the patient's PH.
  • Confirmed diagnosis of Group 3 PH associated with lung diseases and or hypoxia other than fibrotic ILD, as outlined in Inclusion Criterion 2.
  • Patients receiving inhaled treprostinil (Yutrepia™) at Baseline. Patients receiving other forms of PH therapy will be eligible for enrollment.

Trial locations and contacts

71 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

United Therapeutics Global Medical Information contact

919-485-8350

clinicaltrials@unither.com

71 sites in 2 countries

United States70 sites, 70 recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131

    Lana Melendres-Groves, MD, 505-272-4751

    Recruiting

  • AnMed Health

    Anderson, South Carolina, 29621

    Abhijit Raval, MD, 864-512-5667

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Aaron Trammell, MD, MSc, 404-778-5736

    Recruiting

  • University of Colorado - Anschutz Medical Campus

    Aurora, Colorado, 80045

    Todd Bull, MD, 720-848-5300

    Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

    Steven Cassady, MD, 410-225-8301

    Recruiting

  • Summit Health

    Bend, Oregon, 97701

    Jeremy Feldman, MD, 541-382-2811

    Recruiting

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

    Douglas Corwin, MD, 484-526-3890

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Tejaswini Kulkarni, MD, 205-934-3411

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

    Hubert Ford, MD, 984-974-5703

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Denise Sese, MD, 843-792-9200

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Michael Cuttica, MD, 312-695-4077

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Jean Elwing, MD, 513-475-8523

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Maroun Matta, MD, 440-435-3029

    Recruiting

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

    Alice Goyanes, MD, 216-444-6503

    Recruiting

  • Southeastern Cardiology Associates

    Columbus, Georgia, 31904

    Hunter Champion, MD, PhD, FAHA, 706-243-4500

    Recruiting

  • Ohio State Richard M. Ross Heart Hospital

    Columbus, Ohio, 43210

    Elie Homsy, MD, 614-293-8000

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Susan Mathai, MD, 214-820-6856

    Recruiting

  • UT Southwest Medical Center Heart and Lung Clinic

    Dallas, Texas, 75390

    Kelly Chin, MD, 214-645-6616

    Recruiting

  • National Jewish Health

    Denver, Colorado, 80206

    Marjorie George, MD

    Beatrice Kwarteng, 303-398-1553, KWARTENGB@NJHealth.org

    Recruiting

  • Duke University School of Medicine

    Durham, North Carolina, 27710

    Sudarshan Rajagopal, MD, PhD, 919-620-5300

    Recruiting

  • Inova Medical Group

    Falls Church, Virginia, 22042

    Christopher Thomas, MD, 703-776-2986

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Ali Ataya, MD, 352-273-8740

    Recruiting

  • Pulmonix, LLC

    Greensboro, North Carolina, 27403

    Matthew Hunsucker, MD, 336-522-8999

    Recruiting

  • East Carolina University Health

    Greenville, North Carolina, 27834

    Veeranna Maddipati, MD, 252-744-1600

    Recruiting

  • Houston Methodist

    Houston, Texas, 77030

    Meagan Chavarria, NP, 713-441-7779

    Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Rodeo Abrencillo, MD, 832-325-7100

    Recruiting

  • Marshall Health

    Huntington, West Virginia, 25701

    Amro Al-Astal, MD, 304-691-1000

    Recruiting

  • Ascension St. Vincent

    Indianapolis, Indiana, 46260

    Sangita Sudharshan, MD, 317-338-6666

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Leslie Spikes, MD, 913-588-6045

    Recruiting

  • StatCare Pulmonary Consultants and Center for Biomedical Research

    Knoxville, Tennessee, 37909

    Kunal Gada, MD, 865-934-2670

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Jeffrey Stewart, MD, 603-650-5533

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Yuri Matusov, MD, 310-423-8784

    Recruiting

  • Norton Pulmonary Specialists

    Louisville, Kentucky, 40202

    John McConnell, MD, 502-587-8000

    Recruiting

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

    James Runo, MD, 608-263-7203

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Daniel Dilling, MD, 888-584-7888

    Recruiting

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Eric Roberts, MD, 414-646-2438

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Kenneth Presberg, MD, 414-955-7040

    Recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07960

    Abhishek Singh, MD, PhD, 973-971-4179

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84157

    Erin Blackstock, MD, 801-507-4800

    Recruiting

  • NCH Research Institute

    Naples, Florida, 34102

    David Lindner, DO, 239-624-8387

    Recruiting

  • HMH Jersey Shore University Medical Ctr.

    Neptune City, New Jersey, 07753

    Eric Costanzo, DO, 732-775-9075

    Recruiting

  • Northwell Health

    New Hyde Park, New York, 11042

    Arunabh Talwar, MD, 516-465-5433

    Recruiting

  • University Medical Center - New Orleans

    New Orleans, Louisiana, 70112

    Amita Krishnan, MD, 504-568-4634

    Recruiting

  • New York University Langone Medical Center

    New York, New York, 10016

    Roxana Sulica, MD, 212-263-1260

    Recruiting

  • New York Presbyterian Hospital - Weill Cornell Medicine

    New York, New York, 10021

    Robert Kaner, MD, 646-962-2333

    Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

    Michael Eggert, MD, 757-388-9138

    Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

    Muhyaldeen Dia, MD, 708-636-7575

    Recruiting

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Syed Hussain, MD, 405-271-6253

    Recruiting

  • Advent Health Medical Group Advanced Lung Disease

    Orlando, Florida, 32804

    Melisa Wilson, DNP, APRN, BC, 407-303-3638

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Jason Fritz, MD, 215-662-8766

    Recruiting

  • Thomas Jefferson University - Sidney Kimmel Medical College

    Philadelphia, Pennsylvania, 19107

    Gautam George, MD, 215-955-6591

    Recruiting

  • Temple Lung Center

    Philadelphia, Pennsylvania, 19140

    Sheila Weaver, DO, 800-836-7536

    Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

    Ahmed Sadek, MD, 800-836-7536

    Recruiting

  • Banner Health - University Medical Center Phoenix

    Phoenix, Arizona, 85006

    Karim El-Kersh, MD, 602-229-2200

    Recruiting

  • Legacy Research Institute

    Portland, Oregon, 97210

    Steven Sears, DO, 503-413-5702

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Jeffrey Robinson, MD, 503-297-3778

    Recruiting

  • Wakemed Health and Hospital

    Raleigh, North Carolina, 27610-1231

    Kishan Parikh, MD, 919-350-8000

    Recruiting

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230

    Shilpa Johri, MD, 804-320-4243

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Jared Dyer, DO, 804-828-7929

    Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

    Hilary DuBrock, MD, 507-284-2511

    Recruiting

  • University of Rochester Medicine

    Rochester, New York, 14623

    R. James White, MD, PhD, 585-275-4861

    Recruiting

  • UC Davis Health Medical Center

    Sacramento, California, 95817

    Namita Sood, MD, FCCP, 916-734-8230

    Recruiting

  • University of Utah Health

    Salt Lake City, Utah, 84108

    Emily Beck, MD, 801-581-2000

    Recruiting

  • Intercoastal Medical Group

    Sarasota, Florida, 34239

    Ryan Dunn, MD, 941-379-1799

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Robert Case, MD, 314-454-8764

    Recruiting

  • Tampa General Hospital/University of South Florida Health

    Tampa, Florida, 33606

    Ricardo Restrepo-Jaramillo, MD, 813-821-8038

    Recruiting

  • Corewell Health Beamont Troy Hospital

    Troy, Michigan, 48085-1128

    Samuel Allen, DO, 248-964-9490

    Recruiting

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

    Steven Stroud, MD, 918-574-9003

    Recruiting

  • Pasquerilla Healthcare Center - Georgetown University

    Washington D.C., District of Columbia, 20007

    Tunay Kuru, MD, 202-444-8830

    Recruiting

  • Weston Hospital - Cleveland Clinic Florida

    Weston, Florida, 33331

    David Zisman, MD, 877-463-2010

    Recruiting

Other trials in United States

Puerto Rico1 site, 1 recruiting

  • Auxilio Mutuo Hospital

    Guaynabo, Puerto Rico, 00968

    Alvaro Aranda, MD, 787-200-4545

    Recruiting

Other trials in Puerto Rico

About this study

This is a prospective, real world, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and interstitial lung disease (ILD).

Read the detailed description

The purpose of this study is to capture and analyze patient characteristics, treatment patterns, and clinical outcomes of patients with PH-ILD, with the goal of enhancing our current understanding of the disease state and its treatment outcomes. The study also aims to describe the disease trajectory of ILD patients at risk of pulmonary hypertension (PH).

In this registry, patients will be enrolled into 1 of 4 cohorts. Cohort 1 will include approximately 200 patients who are not receiving inhaled treprostinil at time of study enrollment. Cohort 2 will include approximately 300 patients who are newly initiated on Tyvaso/Tyvaso DPI. Cohort 3 will include approximately 300 patients who have been receiving Tyvaso/Tyvaso DPI for >90 days. Cohort 4 will include approximately 100 ILD patients with a prior right heart catheterization (RHC) not meeting the definition of PH.

As part of the registry, assessments will be completed for data collection in 6- or 12 month intervals, unless the data are already available via standard of care. This patient registry will follow patients for up to 5 years after enrollment.

Assessments include pulmonary function tests (PFTs) including diffusing capacity of the lungs for carbon monoxide (DLCO); high resolution computed tomography (HRCT); vital signs; 6-Minute Walk Test; blood draw for plasma N-terminal pro-BNP (NT-proBNP) concentration, genetics analysis, biomarker analysis; echocardiography; EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L); King's Brief Interstitial Lung Disease Questionnaire (K-BILD); Living with Pulmonary Fibrosis Questionnaire (L-PF); Therapy Administration Questionnaire; emPHasis-10 Questionnaire; healthcare resource utilization; current medications and rehabilitation; WHO functional class; transplant status; palliative care data; survival data; and RHC.

Being tested
Prospective study assessments
Keywords
pulmonary hypertension, interstitial lung disease, pulmonary hypertension associated with interstitial lung disease
Medical subject headings
Hypoxia, Hypertension, Pulmonary, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prospective study assessmentsOther

    Patients will complete prospective assessments at 6- and 12-month intervals for up to 5 years. There will be 1 check in at the first 3 months of enrollment. Follow up visits will include a ±45 day visit window. If an assessment is performed within 45 days of the visit window as part of the patient's standard of care, those values will be used in place of a prospective assessment.

Study groups in NCT06388421
Study groupRoleWhat they receive
Cohort 1Cohort 1 will include approximately 200 patients who are not receiving inhaled treprostinil at time of study enrollment.
Receives: Other: Prospective study assessments
Cohort 2Cohort 2 will include approximately 300 patients who are newly initiated on Tyvaso/Tyvaso DPI. For patients to be eligible for Cohort 2, they must have initiated Tyvaso/Tyvaso DPI at Baseline or ≤ 90 days prior to Baseline.
Receives: Other: Prospective study assessments
Cohort 3Cohort 3 will include approximately 300 patients who have been receiving Tyvaso/Tyvaso DPI for > 90 days prior to Baseline.
Receives: Other: Prospective study assessments
Cohort 4Cohort 4 will include approximately 100 ILD patients with a prior RHC not meeting the definition of PH but has a pulmonary artery wedge pressure ≤ 15 mmHg.
Receives: Other: Prospective study assessments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline characteristics as described by demographics, medical history, ILD history, PH history, family history (comorbidities), and diagnostic right heart catheterization values.

    Measured: Baseline

Secondary outcomes (1)

  1. Changes in clinical features relating to patients' interstitial lung disease and pulmonary hypertension

    Measured: Followed prospectively for a maximum of 5 years from date of enrollment into the registry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start23 Jan 2025
  3. Primary completion1 Sep 2030 (estimated)
  4. Study completion30 Nov 2030 (estimated)

Resources

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
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06388421
Sponsor's protocol ID
GMS-PH-401
Status last verified
Mar 2026
First submitted
12 Apr 2024
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Hypertension Due to Lung Diseases and Hypoxia and Pulmonary Hypertension, run by United Therapeutics at 71 sites in 2 countries.

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 15 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Puerto Rico. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact United Therapeutics Global Medical Information (919-485-8350, clinicaltrials@unither.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline characteristics as described by demographics, medical history, ILD history, PH history, family history (comorbidities), and diagnostic right heart catheterization values. (time frame: Baseline). 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 NCT06388421.

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 26 Aug 2026.

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