DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Recruiting · NCT06388421 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Prospective study assessments
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
60 locations listed across 32 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Banner Health - University Medical Center Phoenix - Phoenix, Arizona, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- UC Davis Health Medical Center - Sacramento, California, United States
- University of Colorado - Anschutz Medical Campus - Aurora, Colorado, United States
- National Jewish Health - Denver, Colorado, United States
- Pasquerilla Healthcare Center - Georgetown University - Washington D.C., District of Columbia, United States
- University of Florida - Gainesville, Florida, United States
- NCH Research Institute - Naples, Florida, United States
- Advent Health Medical Group Advanced Lung Disease - Orlando, Florida, United States
- Intercoastal Medical Group - Sarasota, Florida, United States
- Tampa General Hospital/University of South Florida Health - Tampa, Florida, United States
- Weston Hospital - Cleveland Clinic Florida - Weston, Florida, United States
- Emory University - Atlanta, Georgia, United States
- Southeastern Cardiology Associates - Columbus, Georgia, United States
- Northwestern University - Chicago, Illinois, United States
- Loyola University Medical Center - Maywood, Illinois, United States
- Advocate Christ Medical Center - Oak Lawn, Illinois, United States
- Ascension St. Vincent - Indianapolis, Indiana, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- Norton Pulmonary Specialists - Louisville, Kentucky, United States
- University Medical Center - New Orleans - New Orleans, Louisiana, United States
- University of Maryland Medical Center - Baltimore, Maryland, United States
- Corewell Health Beamont Troy Hospital - Troy, Michigan, United States
- Mayo Clinic - Rochester - Rochester, Minnesota, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire, United States
- Morristown Medical Center - Morristown, New Jersey, United States
- HMH Jersey Shore University Medical Ctr. - Neptune City, New Jersey, United States
- University of New Mexico Health Sciences Center - Albuquerque, New Mexico, United States
- Northwell Health - New Hyde Park, New York, United States
- New York University Langone Medical Center - New York, New York, United States
- New York Presbyterian Hospital - Weill Cornell Medicine - New York, New York, United States
- University of Rochester Medicine - Rochester, New York, United States
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- Duke University School of Medicine - Durham, North Carolina, United States
- Pulmonix, LLC - Greensboro, North Carolina, United States
- East Carolina University Health - Greenville, North Carolina, United States
- Wakemed Health and Hospital - Raleigh, North Carolina, United States
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- The Cleveland Clinic - Cleveland, Ohio, United States
- Ohio State Richard M. Ross Heart Hospital - Columbus, Ohio, United States
- The University of Oklahoma Health Sciences Center - Oklahoma City, Oklahoma, United States
- Oklahoma Heart Institute - Tulsa, Oklahoma, United States
- Summit Health - Bend, Oregon, United States
- Legacy Research Institute - Portland, Oregon, United States
- Oregon Health & Science University - Portland, Oregon, United States
- St. Luke's University Health Network - Bethlehem, Pennsylvania, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Thomas Jefferson University - Sidney Kimmel Medical College - Philadelphia, Pennsylvania, United States
- Temple Lung Center - Philadelphia, Pennsylvania, United States
- Temple University Hospital - Philadelphia, Pennsylvania, United States
- AnMed Health - Anderson, South Carolina, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- StatCare Pulmonary Consultants and Center for Biomedical Research - Knoxville, Tennessee, United States
- Baylor University Medical Center - Dallas, Texas, United States
- UT Southwest Medical Center Heart and Lung Clinic - Dallas, Texas, United States
- Houston Methodist - Houston, Texas, United States
- University of Texas Health Science Center at Houston - Houston, Texas, United States
Showing 60 of 71 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →