Interstitial Lung Disease Clinical Trials

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

Status: Recruiting
Location: See all (61) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Banner Health - University Medical Center Phoenix
RECRUITING
Phoenix
Colorado
University of Colorado - Anschutz Medical Campus
RECRUITING
Aurora
National Jewish Health
RECRUITING
Denver
Washington, D.c.
Pasquerilla Healthcare Center - Georgetown University
RECRUITING
Washington D.c.
Florida
University of Florida
RECRUITING
Gainesville
NCH Research Institute
RECRUITING
Naples
Advent Health Medical Group Advanced Lung Disease
RECRUITING
Orlando
Intercoastal Medical Group
RECRUITING
Sarasota
Tampa General Hospital/University of South Florida Health
RECRUITING
Tampa
Weston Hospital - Cleveland Clinic Florida
RECRUITING
Weston
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Loyola University Medical Center
RECRUITING
Maywood
Advocate Christ Medical Center
RECRUITING
Oak Lawn
Indiana
Ascension St. Vincent
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
Norton Pulmonary Specialists
RECRUITING
Louisville
Louisiana
University Medical Center - New Orleans
RECRUITING
New Orleans
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Duke University School of Medicine
RECRUITING
Durham
Pulmonix, LLC
RECRUITING
Greensboro
East Carolina University Health
RECRUITING
Greenville
Wakemed Health and Hospital
RECRUITING
Raleigh
New Jersey
Morristown Medical Center
RECRUITING
Morristown
New Mexico
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
New York
Northwell Health
RECRUITING
New Hyde Park
New York Presbyterian Hospital - Weill Cornell Medicine
RECRUITING
New York
New York University Langone Medical Center
RECRUITING
New York
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
The Cleveland Clinic
RECRUITING
Cleveland
Ohio State Richard M. Ross Heart Hospital
RECRUITING
Columbus
Oklahoma
The University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oklahoma Heart Institute
RECRUITING
Tulsa
Oregon
Summit Health
RECRUITING
Bend
Legacy Research Institute
RECRUITING
Portland
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
St. Luke's University Health Network
RECRUITING
Bethlehem
Temple Lung Center
RECRUITING
Philadelphia
Temple University Hospital
RECRUITING
Philadelphia
Thomas Jefferson University - Sidney Kimmel Medical College
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
AnMed Health
RECRUITING
Anderson
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
StatCare Pulmonary Consultants and Center for Biomedical Research
RECRUITING
Knoxville
Texas
Baylor University Medical Center
RECRUITING
Dallas
UT Southwest Medical Center Heart and Lung Clinic
RECRUITING
Dallas
Houston Methodist
RECRUITING
Houston
University of Texas Health Science Center at Houston
RECRUITING
Houston
Utah
Intermountain Medical Center
RECRUITING
Murray
University of Utah Health
RECRUITING
Salt Lake City
Virginia
Inova Medical Group
RECRUITING
Falls Church
Pulmonary Associates of Richmond, Inc.
RECRUITING
Richmond
Virginia Commonwealth University
RECRUITING
Richmond
Wisconsin
University of Wisconsin Hospital and Clinics
RECRUITING
Madison
Aurora St. Luke's Medical Center
RECRUITING
Milwaukee
Medical College of Wisconsin
RECRUITING
Milwaukee
West Virginia
Marshall Health
RECRUITING
Huntington
Other Locations
Puerto Rico
Auxilio Mutuo Hospital
RECRUITING
Guaynabo
Contact Information
Primary
United Therapeutics Global Medical Information
clinicaltrials@unither.com
919-485-8350
Time Frame
Start Date: 2025-01-23
Estimated Completion Date: 2030-11-30
Participants
Target number of participants: 900
Treatments
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.
Sponsors
Leads: United Therapeutics

This content was sourced from clinicaltrials.gov