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

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

This is a prospective, non-interventional, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged 18 years or older

• Diagnosis of ILD by traditional or HRCT determined by the site/institution that conducted the HRCT

• Patients with connective tissue disease must have a baseline forced vital capacity of \<70%

• RHC confirmed PH (mean pulmonary artery pressure \>20 mmHg, pulmonary arterial 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

⁃ ≤60 days prior to Baseline

• For patients to be eligible for Cohort 3, they must be receiving Tyvaso/Tyvaso DPI at Baseline and for \>60 days prior to Baseline

• Co-enrollment in other observational or interventional studies is permitted

• 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
Colorado
University of Colorado - Anschutz Medical Campus
RECRUITING
Aurora
Florida
NCH Research Institute
RECRUITING
Naples
Intercoastal Medical Group
RECRUITING
Sarasota
Tampa General Hospital/University of South Florida Health
RECRUITING
Tampa
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
North Carolina
Pulmonix, LLC
RECRUITING
Greensboro
East Carolina University Health
RECRUITING
Greenville
Wakemed Health and Hospital
RECRUITING
Raleigh
New Mexico
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
New York
Northwell Health
RECRUITING
New Hyde Park
New York University Langone Medical Center
RECRUITING
New York
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Ohio State Richard M. Ross Heart Hospital
RECRUITING
Columbus
Oklahoma
Oklahoma Heart Institute
RECRUITING
Tulsa
Oregon
Summit Health
RECRUITING
Bend
Legacy Research Institute
RECRUITING
Portland
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Temple Lung Center
RECRUITING
Philadelphia
Temple University Hospital
RECRUITING
Philadelphia
Thomas Jefferson University - Sidney Kimmel Medical College
RECRUITING
Philadelphia
South Carolina
AnMed Health
RECRUITING
Anderson
Tennessee
StatCare Pulmonary Consultants and Center for Biomedical Research
RECRUITING
Knoxville
Texas
Baylor University Medical Center
RECRUITING
Dallas
Houston Methodist
RECRUITING
Houston
Utah
Intermountain Medical Center
RECRUITING
Murray
Virginia
Pulmonary Associates of Richmond, Inc.
RECRUITING
Richmond
Wisconsin
Aurora St. Luke's Medical Center
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: 1000
Treatments
Cohort 1
Cohort 1 will include approximately 500 patients who are not receiving inhaled treprostinil at time of study enrollment.
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.
Cohort 3
Cohort 3 will include approximately 350 patients who have been receiving Tyvaso/Tyvaso DPI for \> 60 days prior to Baseline.
Sponsors
Leads: United Therapeutics

This content was sourced from clinicaltrials.gov