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

Recruiting now

Conditions studied: Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Pulmonary Hypertension, Interstitial Lung Disease

In brief

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).

Key facts

Study ID

NCT06388421

Run by

United Therapeutics

People needed

900

Starts

2025-01-23

Expected to finish

2030-11-30

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Banner Health - University Medical Center Phoenix — Phoenix, Arizona, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• University of Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• National Jewish Health — Denver, Colorado, United States (enrolling)
• Pasquerilla Healthcare Center - Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• NCH Research Institute — Naples, Florida, United States (enrolling)
• Advent Health Medical Group Advanced Lung Disease — Orlando, Florida, United States (enrolling)
• Intercoastal Medical Group — Sarasota, Florida, United States (enrolling)
• Tampa General Hospital/University of South Florida Health — Tampa, Florida, United States (enrolling)
• Weston Hospital - Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Loyola University Medical Center — Maywood, Illinois, United States (enrolling)
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States (enrolling)
• Ascension St. Vincent — Indianapolis, Indiana, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Norton Pulmonary Specialists — Louisville, Kentucky, United States (enrolling)
• University Medical Center - New Orleans — New Orleans, Louisiana, United States (enrolling)
• University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• Morristown Medical Center — Morristown, New Jersey, United States (enrolling)
• HMH Jersey Shore University Medical Ctr. — Neptune City, New Jersey, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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