Clinical trial NCT05776225: Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection
Official title: Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection (PHINDER)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Pulmonary Hypertension
Keywords: ILD
PH
PH-ILD
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PH-ILD being treated in any setting, including academic, community, etc.

Brief summary: Study GMS-PH-001 is a multicenter, open-label, non-randomized study to prospectively evaluate screening strategies of pulmonary hypertension (PH) in patients with interstitial lung disease (ILD).

Detailed description: 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.
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
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 medication.
3. Diagnosed with chronic obstructive pulmonary disease.
4. Uncontrolled or untreated sleep apnea.
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.

Primary outcomes:
measure: Percentage of patients with PH as indicated by RHC
timeFrame: Through study completion, approximately 3 weeks.
Secondary outcomes:
measure: Percentage of patients with severe PH as indicated by RHC
timeFrame: Through study completion, approximately 3 weeks.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Lakeland
country: United States
facility: Lakeland Regional Health
state: Florida
city: Naples
country: United States
facility: NCH Healthcare System
state: Florida
city: Tampa
country: United States
facility: University of South Florida Health
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Austell
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Chicago
country: United States
facility: Loyola University Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Glenview
country: United States
facility: NorthShore University Health System
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: New Orleans
country: United States
facility: LSU Health Sciences Center New Orleans
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Int Med Pulmonary and Critical Care
state: Michigan
city: Okemos
country: United States
facility: Mclaren Greater Lansing
state: Michigan
city: Hannibal
country: United States
facility: Blessing Health Hannibal
state: Missouri
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Pulmonix, LLC
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Portland
country: United States
facility: Legacy Health
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Pulmonary and Sleep Medicine
state: South Carolina
city: Columbia
country: United States
facility: Prisma Health
state: South Carolina
city: Knoxville
country: United States
facility: StatCare Pulmonary Consultants
state: Tennessee
city: Denison
country: United States
facility: Premier Pulmonary Critical Care and Sleep Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Murray
country: United States
facility: Intermountain Healthcare
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond
state: Virginia
city: Spokane
country: United States
facility: Providence Medical Research Center
state: Washington
city: Huntington
country: United States
facility: Marshall Health
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: