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Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection
NCT05776225 · United Therapeutics
In plain English
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Official title
Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection (PHINDER)
About this study
In this study, subjects will undergo a broad range of clinical assessments that are potentially associated with PH. Study data will be used to identify and weigh specific clinical parameters based on their prognostic significance for right heart catheterization (RHC)-confirmed PH. There is no study drug under investigation in this study. The study consists of 2 study visits: a Screening Visit and Study Visit 1.
Clinical assessments include pulmonary function tests (PFTs); high resolution computed tomography (HRCT); physical examination; 6-Minute Walk Test; blood draw for clinical laboratory parameters, plasma brain natriuretic peptide (BNP) concentration and plasma N-terminal pro-BNP (NT-proBNP) concentration; echocardiography; University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ); King's Brief Interstitial Lung Disease Questionnaire (K-BILD); 36-Item Short Form Survey (SF-36); Pulmonary Hypertension Functional Classification Self Report (PH-FC-SR); Investigator's Suspicion of PH Questionnaire; adverse event (AE) monitoring; and RHC.
As the primary objective of this study is to collect a broad range of clinical parameters in patients with ILD, it is expected that numerous exploratory and post-hoc analyses will be performed to identify and weigh specific parameters based on their prognostic significance for PH in this patient population with the goal of developing a screening algorithm for PH in patients with ILD.
Eligibility criteria
Inclusion Criteria
1. Patient gives voluntary written informed consent to participate in the study and are capable of reading and understanding questionnaires or forms in English or Spanish.
2. Patients with a diagnosis of ILD based on computed tomography imaging, including:
1. Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
2. Connective tissue disease-associated ILD with forced vital capacity (FVC) \<70%
3. Hypersensitivity pneumonitis
4. Scleroderma-related ILD
5. Autoimmune ILD
6. Nonspecific interstitial pneumonia
7. Occupational lung disease
8. Combined pulmonary fibrosis and emphysema with mild emphysema on lung imaging as determined by the Investigator
3. Patients must have at least 2 signs or symptoms suggestive of PH, as specified by the study protocol.
Exclusion Criteria
1. Prior RHC with mPAP \>20 mmHg.
2. Currently on a Food and Drug Administration (FDA)-approved pulmonary arterial hypertension (PAH) medication for the treatment of PAH.
3. Diagnosed with chronic obstructive pulmonary disease (CPFE with mild emphysema notwithstanding).
4. Uncontrolled or untreated moderate to severe sleep apnea as determined by the patient's physician.
5. Pulmonary embolism within the past 3 months.
6. History of ischemic heart disease or left-sided myocardial dysfunction within 12 months of Screening, defined as left ventricular ejection fraction \<40% or pulmonary capillary wedge pressure \>15 mmHg.
7. Any other clinical features that, in the opinion of the Investigator, might adversely affect interpretation of study data or study safety, or make the patient unsuitable for RHC or HRCT (e.g., pregnancy).
Study design
Enrollment target: 300 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-08-11
Estimated completion: 2026-04
Last updated: 2026-02-10
Interventions
Procedure: Right heart catheterization (RHC)
Primary outcomes
- • Percentage of patients with PH as indicated by RHC (Through study completion, approximately 3 weeks.)
Sponsor
United Therapeutics · industry
Contacts & investigators
ContactUnited Therapeutics Global Medical Information · contact · clinicaltrials@unither.com · 919-485-8350
All locations (42)
Pulmonary AssociatesRecruiting
Phoenix, Arizona, United States
Hartford HospitalRecruiting
Hartford, Connecticut, United States
Lakeland Regional HealthRecruiting
Lakeland, Florida, United States
NCH Healthcare SystemRecruiting
Naples, Florida, United States
University of South Florida HealthRecruiting
Tampa, Florida, United States
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
Emory University HospitalRecruiting
Atlanta, Georgia, United States
Piedmont HealthcareRecruiting
Austell, Georgia, United States
Loyola University ChicagoRecruiting
Chicago, Illinois, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
NorthShore University Health SystemRecruiting
Glenview, Illinois, United States
University of Kentucky Medical CenterRecruiting
Lexington, Kentucky, United States
LSU Health Sciences Center New OrleansRecruiting
New Orleans, Louisiana, United States
University of Michigan Int Med Pulmonary and Critical CareRecruiting
Ann Arbor, Michigan, United States
Mclaren Greater LansingRecruiting
Okemos, Michigan, United States
Blessing Health HannibalRecruiting
Hannibal, Missouri, United States
Renown Regional Medical CenterRecruiting
Reno, Nevada, United States
Dartmouth Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
Jersey Shore University Medical CenterRecruiting
Neptune City, New Jersey, United States
NYU Langone Medical CenterRecruiting
New York, New York, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
Pulmonix, LLCRecruiting
Greensboro, North Carolina, United States
East Carolina UniversityRecruiting
Greenville, North Carolina, United States
Legacy HealthRecruiting
Portland, Oregon, United States
St. Luke's University Health NetworkRecruiting
Bethlehem, Pennsylvania, United States
AnMed Health Pulmonary and Sleep MedicineRecruiting
Anderson, South Carolina, United States
Prisma HealthRecruiting
Columbia, South Carolina, United States
StatCare Pulmonary ConsultantsRecruiting
Knoxville, Tennessee, United States
Premier Pulmonary Critical Care and Sleep MedicineRecruiting
Denison, Texas, United States
Houston Methodist HospitalRecruiting
Houston, Texas, United States
The University of Texas Health Science Center at San AntonioRecruiting
San Antonio, Texas, United States
Intermountain HealthcareRecruiting
Murray, Utah, United States
University of Utah HealthRecruiting
Salt Lake City, Utah, United States
The University of Vermont Medical CenterRecruiting
Burlington, Vermont, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Inova Fairfax HospitalRecruiting
Falls Church, Virginia, United States
Sentara Cardiovascular Research InstituteRecruiting
Norfolk, Virginia, United States
Pulmonary Associates of RichmondRecruiting
Richmond, Virginia, United States
Providence Medical Research CenterCompleted
Spokane, Washington, United States
Marshall HealthRecruiting
Huntington, West Virginia, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States