Recruiting

Observational Study

Sponsor:

United Therapeutics

Code:

NCT06388421

Conditions

Pulmonary Hypertension Due to Lung Diseases and Hypoxia

Pulmonary Hypertension

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prospective study assessments

Study Details

Brief 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).

Conditions

Pulmonary Hypertension Due to Lung Diseases and Hypoxia

Pulmonary Hypertension

Interstitial Lung Disease

Study ID

NCT06388421

Start date

Jan 23, 2025

Status verified date

Mar, 2026

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Sep 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

900 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Cohort 1 will include approximately 200 patients who are not receiving inhaled treprostinil at time of study enrollment.

Cohort 2

Cohort 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.

Cohort 3

Cohort 3 will include approximately 300 patients who have been receiving Tyvaso/Tyvaso DPI for > 90 days prior to Baseline.

Cohort 4

Cohort 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.

Interventions

Prospective study assessments

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.

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 ]

Central Contacts and Locations

Central contacts

United Therapeutics Global Medical Information

919-485-8350clinicaltrials@unither.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Tejaswini Kulkarni, MD

205-934-3411

Banner Health - University Medical Center Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Karim El-Kersh, MD

602-229-2200

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Yuri Matusov, MD

310-423-8784

UC Davis Health Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Namita Sood, MD, FCCP

916-734-8230

University of Colorado - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Todd Bull, MD

720-848-5300

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Beatrice Kwarteng

303-398-1553KWARTENGB@NJHealth.org

Pasquerilla Healthcare Center - Georgetown University

Recruiting

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

Contacts

Tunay Kuru, MD

202-444-8830

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Ali Ataya, MD

352-273-8740

NCH Research Institute

Recruiting

Naples, Florida, United States, 34102

Contacts

David Lindner, DO

239-624-8387

Advent Health Medical Group Advanced Lung Disease

Recruiting

Orlando, Florida, United States, 32804

Contacts

Melisa Wilson, DNP, APRN, BC

407-303-3638

Intercoastal Medical Group

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Ryan Dunn, MD

941-379-1799

Tampa General Hospital/University of South Florida Health

Recruiting

Tampa, Florida, United States, 33606

Contacts

Ricardo Restrepo-Jaramillo, MD

813-821-8038

Weston Hospital - Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Contacts

David Zisman, MD

877-463-2010

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Aaron Trammell, MD, MSc

404-778-5736

Southeastern Cardiology Associates

Recruiting

Columbus, Georgia, United States, 31904

Contacts

Hunter Champion, MD, PhD, FAHA

706-243-4500

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Michael Cuttica, MD

312-695-4077

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Daniel Dilling, MD

888-584-7888

Advocate Christ Medical Center

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Muhyaldeen Dia, MD

708-636-7575

Ascension St. Vincent

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Sangita Sudharshan, MD

317-338-6666

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Leslie Spikes, MD

913-588-6045

Norton Pulmonary Specialists

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

John McConnell, MD

502-587-8000

University Medical Center - New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Amita Krishnan, MD

504-568-4634

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Steven Cassady, MD

410-225-8301

Corewell Health Beamont Troy Hospital

Recruiting

Troy, Michigan, United States, 48085-1128

Contacts

Samuel Allen, DO

248-964-9490

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Hilary DuBrock, MD

507-284-2511

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Robert Case, MD

314-454-8764

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

Jeffrey Stewart, MD

603-650-5533

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Abhishek Singh, MD, PhD

973-971-4179

HMH Jersey Shore University Medical Ctr.

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Eric Costanzo, DO

732-775-9075

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Lana Melendres-Groves, MD

505-272-4751

Northwell Health

Recruiting

New Hyde Park, New York, United States, 11042

Contacts

Arunabh Talwar, MD

516-465-5433

New York University Langone Medical Center

Recruiting

New York, New York, United States, 10016

Contacts

Roxana Sulica, MD

212-263-1260

New York Presbyterian Hospital - Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Robert Kaner, MD

646-962-2333

University of Rochester Medicine

Recruiting

Rochester, New York, United States, 14623

Contacts

R. James White, MD, PhD

585-275-4861

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Hubert Ford, MD

984-974-5703

Duke University School of Medicine

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Sudarshan Rajagopal, MD, PhD

919-620-5300

Pulmonix, LLC

Recruiting

Greensboro, North Carolina, United States, 27403

Contacts

Matthew Hunsucker, MD

336-522-8999

East Carolina University Health

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Veeranna Maddipati, MD

252-744-1600

Wakemed Health and Hospital

Recruiting

Raleigh, North Carolina, United States, 27610-1231

Contacts

Kishan Parikh, MD

919-350-8000

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Jean Elwing, MD

513-475-8523

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Maroun Matta, MD

440-435-3029

The Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Alice Goyanes, MD

216-444-6503

Ohio State Richard M. Ross Heart Hospital

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Elie Homsy, MD

614-293-8000

The University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Syed Hussain, MD

405-271-6253

Oklahoma Heart Institute

Recruiting

Tulsa, Oklahoma, United States, 74104

Contacts

Steven Stroud, MD

918-574-9003

Summit Health

Recruiting

Bend, Oregon, United States, 97701

Contacts

Jeremy Feldman, MD

541-382-2811

Legacy Research Institute

Recruiting

Portland, Oregon, United States, 97210

Contacts

Steven Sears, DO

503-413-5702

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jeffrey Robinson, MD

503-297-3778

St. Luke's University Health Network

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Douglas Corwin, MD

484-526-3890

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jason Fritz, MD

215-662-8766

Thomas Jefferson University - Sidney Kimmel Medical College

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Gautam George, MD

215-955-6591

Temple Lung Center

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Sheila Weaver, DO

800-836-7536

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Ahmed Sadek, MD

800-836-7536

AnMed Health

Recruiting

Anderson, South Carolina, United States, 29621

Contacts

Abhijit Raval, MD

864-512-5667

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Denise Sese, MD

843-792-9200

StatCare Pulmonary Consultants and Center for Biomedical Research

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

Kunal Gada, MD

865-934-2670

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Susan Mathai, MD

214-820-6856

UT Southwest Medical Center Heart and Lung Clinic

Recruiting

Dallas, Texas, United States, 75390

Contacts

Kelly Chin, MD

214-645-6616

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Meagan Chavarria, NP

713-441-7779

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Rodeo Abrencillo, MD

832-325-7100

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84157

Contacts

Erin Blackstock, MD

801-507-4800

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Emily Beck, MD

801-581-2000

Inova Medical Group

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Christopher Thomas, MD

703-776-2986

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Michael Eggert, MD

757-388-9138

Pulmonary Associates of Richmond, Inc.

Recruiting

Richmond, Virginia, United States, 23230

Contacts

Shilpa Johri, MD

804-320-4243

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Jared Dyer, DO

804-828-7929

Marshall Health

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

Amro Al-Astal, MD

304-691-1000

University of Wisconsin Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

James Runo, MD

608-263-7203

Aurora St. Luke's Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Eric Roberts, MD

414-646-2438

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kenneth Presberg, MD

414-955-7040

More Information

Sponsor

United Therapeutics

Last update posted

Aug 26, 2026

Last verified

Mar, 2026

Keywords

  • pulmonary hypertension
  • interstitial lung disease
  • pulmonary hypertension associated with interstitial lung disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by United Therapeutics on 2026-08-26.