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New study to track lung and heart health in 900 patients

NCT ID NCT06388421

Knowledge-focused Sponsor: United Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study is a registry that will follow about 900 adults with both interstitial lung disease and pulmonary hypertension. Researchers will collect information on patients' medical history and track changes in their condition over time. The goal is to better understand these diseases, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged 18 years or older 2. Diagnosis of fibrotic ILD based on high-resolution computed tomography imaging, including but not limited to: 1. Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis 2. Autoimmune ILD 3. Chronic hypersensitivity pneumonitis 4. Nonspecific interstitial pneumonia 5. Occupational lung disease 6. Combined pulmonary fibrosis and emphysema with fibrosis greater than the extent of emphysema on lung imaging as determined by the Investigator 3. 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). 4. For patients to be eligible for Cohort 1, they must not be receiving inhaled treprostinil at Baseline. 5. For patients to be eligible for Cohort 2, they must have initiated Tyvaso/Tyvaso DPI at 1 of the following time points: 1. Baseline 2. ≤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. Exclusion Criteria: 1. Confirmed diagnosis of Group 1, 2, 4, or 5 PH a. 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. 2. Confirmed diagnosis of Group 3 PH associated with lung diseases and or hypoxia other than fibrotic ILD, as outlined in Inclusion Criterion 2. 3. Patients receiving inhaled treprostinil (Yutrepia™) at Baseline. Patients receiving other forms of PH therapy will be eligible for enrollment.

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Conditions

The condition(s) this trial relates to.

Hypoxia interstitial lung disease pulmonary hypertension pulmonary hypertension owing to lung disease and/or hypoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Interstitial lung disease Pulmonary hypertension Pulmonary hypertension due to lung diseases and hypoxia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    71 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Advent Health Medical Group Advanced Lung Disease

    RECRUITING

    Orlando, Florida, 32804, United States

  • Advocate Christ Medical Center

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • AnMed Health

    RECRUITING

    Anderson, South Carolina, 29621, United States

  • Ascension St. Vincent

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Aurora St. Luke's Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Auxilio Mutuo Hospital

    RECRUITING

    Guaynabo, Puerto Rico, 00968, Puerto Rico

  • Banner Health - University Medical Center Phoenix

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Corewell Health Beamont Troy Hospital

    RECRUITING

    Troy, Michigan, 48085-1128, United States

  • Dartmouth Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • Duke University School of Medicine

    RECRUITING

    Durham, North Carolina, 27710, United States

  • East Carolina University Health

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • HMH Jersey Shore University Medical Ctr.

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

  • Inova Medical Group

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Intercoastal Medical Group

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84157, United States

  • Legacy Research Institute

    RECRUITING

    Portland, Oregon, 97210, United States

  • Loyola University Medical Center

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Marshall Health

    RECRUITING

    Huntington, West Virginia, 25701, United States

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • NCH Research Institute

    RECRUITING

    Naples, Florida, 34102, United States

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

  • New York Presbyterian Hospital - Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

  • New York University Langone Medical Center

    RECRUITING

    New York, New York, 10016, United States

  • Northwell Health

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Norton Pulmonary Specialists

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Ohio State Richard M. Ross Heart Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oklahoma Heart Institute

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Pasquerilla Healthcare Center - Georgetown University

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Pulmonary Associates of Richmond, Inc.

    RECRUITING

    Richmond, Virginia, 23230, United States

  • Pulmonix, LLC

    RECRUITING

    Greensboro, North Carolina, 27403, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Southeastern Cardiology Associates

    RECRUITING

    Columbus, Georgia, 31904, United States

  • St. Luke's University Health Network

    RECRUITING

    Bethlehem, Pennsylvania, 18015, United States

  • StatCare Pulmonary Consultants and Center for Biomedical Research

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Summit Health

    RECRUITING

    Bend, Oregon, 97701, United States

  • Tampa General Hospital/University of South Florida Health

    RECRUITING

    Tampa, Florida, 33606, United States

  • Temple Lung Center

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Temple University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • The Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • The University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Thomas Jefferson University - Sidney Kimmel Medical College

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UC Davis Health Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UT Southwest Medical Center Heart and Lung Clinic

    RECRUITING

    Dallas, Texas, 75390, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University Medical Center - New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Colorado - Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Maryland Medical Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of New Mexico Health Sciences Center

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medicine

    RECRUITING

    Rochester, New York, 14623, United States

  • University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Utah Health

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • University of Wisconsin Hospital and Clinics

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Wakemed Health and Hospital

    RECRUITING

    Raleigh, North Carolina, 27610-1231, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weston Hospital - Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331, United States

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