DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT ID: NCT06388421
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2025-01-23
2030-11-30
Brief Summary
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Detailed Description
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In this registry, patients will be enrolled into 1 of 3 cohorts. Cohort 1 will include approximately 500 patients who are not receiving inhaled treprostinil at time of study enrollment. Cohort 2 will include approximately 150 patients who are newly initiated on Tyvaso/Tyvaso DPI. Cohort 3 will include approximately 350 patients who have been receiving Tyvaso/Tyvaso DPI for \>60 days.
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; healthcare resource utilization; current medications and rehabilitation; WHO functional class; transplant status; survival data; and RHC.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 2
Cohort 2 will include approximately 150 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 ≤ 60 days prior to Baseline.
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.
Cohort 3
Cohort 3 will include approximately 350 patients who have been receiving Tyvaso/Tyvaso DPI for \> 60 days prior to Baseline.
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.
Cohort 1
Cohort 1 will include approximately 500 patients who are not receiving inhaled treprostinil at time of study enrollment.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of ILD by traditional or HRCT determined by the site/institution that conducted the HRCT
3. Patients with connective tissue disease must have a baseline forced vital capacity of \<70%
4. RHC confirmed PH (mean pulmonary artery pressure \>20 mmHg, pulmonary arterial wedge pressure ≤15 mmHg, pulmonary vascular resistance \>2 WU).
5. For patients to be eligible for Cohort 1, they must not be receiving inhaled treprostinil at Baseline.
6. 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. ≤60 days prior to Baseline
7. For patients to be eligible for Cohort 3, they must be receiving Tyvaso/Tyvaso DPI at Baseline and for \>60 days prior to Baseline
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
2. Confirmed diagnosis of Group 3 PH related to chronic obstructive pulmonary disease or conditions that cause hypoxemia, such as untreated or inadequately treated obstructive sleep apnea and alveolar hypoventilation disorders
3. Patients receiving Yutrepia (inhaled treprostinil) at Baseline.
18 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Health - University Medical Center Phoenix
Phoenix, Arizona, United States
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, 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
Emory University
Atlanta, 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
Washington University School of Medicine
St Louis, Missouri, United States
Morristown Medical Center
Morristown, 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 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
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
Intermountain Medical Center
Murray, Utah, United States
University of Utah Health
Salt Lake City, Utah, United States
Inova Medical Group
Falls Church, Virginia, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Marshall Health
Huntington, West Virginia, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Auxilio Mutuo Hospital
Guaynabo, Puerto Rico, Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Tejaswini Kulkarni, MD
Role: primary
Karim El-Kersh, MD
Role: primary
Todd Bull, MD
Role: primary
Marjorie George, MD
Role: primary
Ali Ataya, MD
Role: primary
David Lindner, DO
Role: primary
Melisa Wilson, DNP, APRN, BC
Role: primary
Ryan Dunn, MD
Role: primary
Ricardo Restrepo-Jaramillo, MD
Role: primary
Aaron Trammell, MD, MSc
Role: primary
Michael Cuttica, MD
Role: primary
Daniel Dilling, MD
Role: primary
Muhyaldeen Dia, MD
Role: primary
Sangita Sudharshan, MD
Role: primary
Leslie Spikes, MD
Role: primary
John McConnell, MD
Role: primary
Amita Krishnan, MD
Role: primary
Steven Cassady, MD
Role: primary
Robert Case, MD
Role: primary
Abhishek Singh, MD, PhD
Role: primary
Lana Melendres-Groves, MD
Role: primary
Arunabh Talwar, MD
Role: primary
Roxana Sulica, MD
Role: primary
Robert Kaner, MD
Role: primary
Hubert Ford, MD
Role: primary
Sudarshan Rajagopal, MD, PhD
Role: primary
Matthew Hunsucker, MD
Role: primary
Veeranna Maddipati, MD
Role: primary
Kishan Parikh, MD
Role: primary
Jean Elwing, MD
Role: primary
Alice Goyanes, MD
Role: primary
Elie Homsy, MD
Role: primary
Syed Hussain, MD
Role: primary
Steven Stroud, MD
Role: primary
Jeremy Feldman, MD
Role: primary
Steven Sears, DO
Role: primary
Jeffrey Robinson, MD
Role: primary
Douglas Corwin, MD
Role: primary
Jason Fritz, MD
Role: primary
Gautam George, MD
Role: primary
Sheila Weaver, DO
Role: primary
Ahmed Sadek, MD
Role: primary
Abhijit Raval, MD
Role: primary
Denise Sese, MD
Role: primary
Kunal Gada, MD
Role: primary
Susan Mathai, MD
Role: primary
Kelly Chin, MD
Role: primary
Meagan Chavarria, NP
Role: primary
Rodeo Abrencillo, MD
Role: primary
Erin Blackstock, MD
Role: primary
Emily Beck, MD
Role: primary
Christopher Thomas, MD
Role: primary
Shilpa Johri, MD
Role: primary
Jared Dyer, DO
Role: primary
Amro Al-Astal, MD
Role: primary
James Runo, MD
Role: primary
Eric Roberts, MD
Role: primary
Kenneth Presberg, MD
Role: primary
Alvaro Aranda, MD
Role: primary
Other Identifiers
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GMS-PH-401
Identifier Type: -
Identifier Source: org_study_id
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