Ireland
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Recruiting Observational

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

NCT06388421 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2025-01-23
Last updated
2026-08-26

Condition(s) studied

Pulmonary Hypertension Due to Lung Diseases and HypoxiaPulmonary HypertensionInterstitial Lung Disease

Investigational drug(s) / intervention(s)

Prospective study assessments

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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (71)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Banner Health - University Medical Center Phoenix Phoenix Arizona Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
UC Davis Health Medical Center Sacramento California Recruiting
University of Colorado - Anschutz Medical Campus Aurora Colorado Recruiting
National Jewish Health Denver Colorado Recruiting
Pasquerilla Healthcare Center - Georgetown University Washington D.C. District of Columbia Recruiting
University of Florida Gainesville Florida Recruiting
NCH Research Institute Naples Florida Recruiting
Advent Health Medical Group Advanced Lung Disease Orlando Florida Recruiting
Intercoastal Medical Group Sarasota Florida Recruiting
Tampa General Hospital/University of South Florida Health Tampa Florida Recruiting
Weston Hospital - Cleveland Clinic Florida Weston Florida Recruiting
Emory University Atlanta Georgia Recruiting
Southeastern Cardiology Associates Columbus Georgia Recruiting
Northwestern University Chicago Illinois Recruiting
Loyola University Medical Center Maywood Illinois Recruiting
Advocate Christ Medical Center Oak Lawn Illinois Recruiting
Ascension St. Vincent Indianapolis Indiana Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Norton Pulmonary Specialists Louisville Kentucky Recruiting
University Medical Center - New Orleans New Orleans Louisiana Recruiting
University of Maryland Medical Center Baltimore Maryland Recruiting
Corewell Health Beamont Troy Hospital Troy Michigan Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Dartmouth Hitchcock Medical Center Lebanon New Hampshire Recruiting
Morristown Medical Center Morristown New Jersey Recruiting
HMH Jersey Shore University Medical Ctr. Neptune City New Jersey Recruiting
University of New Mexico Health Sciences Center Albuquerque New Mexico Recruiting
Northwell Health New Hyde Park New York Recruiting
New York University Langone Medical Center New York New York Recruiting
New York Presbyterian Hospital - Weill Cornell Medicine New York New York Recruiting
University of Rochester Medicine Rochester New York Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
Duke University School of Medicine Durham North Carolina Recruiting
Pulmonix, LLC Greensboro North Carolina Recruiting
East Carolina University Health Greenville North Carolina Recruiting
Wakemed Health and Hospital Raleigh North Carolina Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Recruiting

+ 31 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06388421 on ClinicalTrials.gov ↗ ← All trials in the USA