DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Start Date
1/23/2025
Completion Date
11/30/2030
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).
Detailed Description
The purpose of this study is to capture and analyze patient characteristics, treatment patterns, and clinical outcomes of patients with PH-ILD, with the goal of enhancing our current understanding of the disease state and its treatment outcomes. The study also aims to describe the disease trajectory of ILD patients at risk of pulmonary hypertension (PH). In this registry, patients will be enrolled into 1 of 4 cohorts. Cohort 1 will include approximately 200 patients who are not receiving inhaled treprostinil at time of study enrollment. Cohort 2 will include approximately 300 patients who are newly initiated on Tyvaso/Tyvaso DPI. Cohort 3 will include approximately 300 patients who have been receiving Tyvaso/Tyvaso DPI for \>90 days. Cohort 4 will include approximately 100 ILD patients with a prior right heart catheterization (RHC) not meeting the definition of PH. As part of the registry, assessments will be completed for data collection in 6- or 12 month intervals, unless the data are already available via standard of care. This patient registry will follow patients for up to 5 years after enrollment. Assessments include pulmonary function tests (PFTs) including diffusing capacity of the lungs for carbon monoxide (DLCO); high resolution computed tomography (HRCT); vital signs; 6-Minute Walk Test; blood draw for plasma N-terminal pro-BNP (NT-proBNP) concentration, genetics analysis, biomarker analysis; echocardiography; EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L); King's Brief Interstitial Lung Disease Questionnaire (K-BILD); Living with Pulmonary Fibrosis Questionnaire (L-PF); Therapy Administration Questionnaire; emPHasis-10 Questionnaire; healthcare resource utilization; current medications and rehabilitation; WHO functional class; transplant status; palliative care data; survival data; and RHC.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Prospective study assessments
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Banner Health - University Medical Center Phoenix
Phoenix, Arizona 85006
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
University of Colorado - Anschutz Medical Campus
Aurora, Colorado 80045
United States
National Jewish Health
Denver, Colorado 80206
United States
Pasquerilla Healthcare Center - Georgetown University
Washington D.C., District of Columbia 20007
United States
University of Florida
Gainesville, Florida 32610
United States
NCH Research Institute
Naples, Florida 34102
United States
Advent Health Medical Group Advanced Lung Disease
Orlando, Florida 32804
United States
Intercoastal Medical Group
Sarasota, Florida 34239
United States
Tampa General Hospital/University of South Florida Health
Tampa, Florida 33606
United States
Weston Hospital - Cleveland Clinic Florida
Weston, Florida 33331
United States
Emory University
Atlanta, Georgia 30322
United States
Northwestern University
Chicago, Illinois 60611
United States
Loyola University Medical Center
Maywood, Illinois 60153
United States
Advocate Christ Medical Center
Oak Lawn, Illinois 60453
United States
Ascension St. Vincent
Indianapolis, Indiana 46260
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Norton Pulmonary Specialists
Louisville, Kentucky 40202
United States
University Medical Center - New Orleans
New Orleans, Louisiana 70112
United States
University of Maryland Medical Center
Baltimore, Maryland 21201
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03766
United States
Morristown Medical Center
Morristown, New Jersey 07960
United States
HMH Jersey Shore University Medical Ctr.
Neptune City, New Jersey 07753
United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico 87131
United States
Northwell Health
New Hyde Park, New York 11042
United States
New York University Langone Medical Center
New York, New York 10016
United States
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York 10021
United States
University of Rochester Medicine
Rochester, New York 14623
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United States
Duke University School of Medicine
Durham, North Carolina 27710
United States
Pulmonix, LLC
Greensboro, North Carolina 27403
United States
East Carolina University Health
Greenville, North Carolina 27834
United States
Wakemed Health and Hospital
Raleigh, North Carolina 27610-1231
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
The Cleveland Clinic
Cleveland, Ohio 44195
United States
Ohio State Richard M. Ross Heart Hospital
Columbus, Ohio 43210
United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Oklahoma Heart Institute
Tulsa, Oklahoma 74104
United States
Summit Health
Bend, Oregon 97701
United States
Legacy Research Institute
Portland, Oregon 97210
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University - Sidney Kimmel Medical College
Philadelphia, Pennsylvania 19107
United States
Temple Lung Center
Philadelphia, Pennsylvania 19140
United States
Temple University Hospital
Philadelphia, Pennsylvania 19140
United States
AnMed Health
Anderson, South Carolina 29621
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
StatCare Pulmonary Consultants and Center for Biomedical Research
Knoxville, Tennessee 37909
United States
Baylor University Medical Center
Dallas, Texas 75246
United States
UT Southwest Medical Center Heart and Lung Clinic
Dallas, Texas 75390
United States
Houston Methodist
Houston, Texas 77030
United States
University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
Intermountain Medical Center
Murray, Utah 84157
United States
University of Utah Health
Salt Lake City, Utah 84108
United States
Inova Medical Group
Falls Church, Virginia 22042
United States
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia 23230
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States
Marshall Health
Huntington, West Virginia 25701
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53792
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Auxilio Mutuo Hospital
Guaynabo, Puerto Rico 00968
Puerto Rico