Screening for pulmonary hypertension in patients with interstitial lung disease
Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection (PHINDER)
United Therapeutics · NCT05776225
This study is trying to find the best ways to check for pulmonary hypertension in people who have interstitial lung disease to catch it earlier and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | United Therapeutics (industry) |
| Locations | 42 sites (Phoenix, Arizona and 41 other locations) |
| Trial ID | NCT05776225 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate screening strategies for pulmonary hypertension (PH) in patients diagnosed with interstitial lung disease (ILD). Participants will undergo a variety of clinical assessments, including pulmonary function tests, echocardiography, and right heart catheterization, to identify clinical parameters that may indicate the presence of PH. The goal is to develop a screening algorithm that can help detect PH earlier in patients with ILD. The study consists of two visits: a Screening Visit and a Study Visit 1.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with interstitial lung disease who exhibit at least two signs or symptoms suggestive of pulmonary hypertension.
Not a fit: Patients who have previously undergone right heart catheterization with a mean pulmonary arterial pressure greater than 20 mmHg or are currently on FDA-approved pulmonary arterial hypertension medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and management of pulmonary hypertension in patients with interstitial lung disease.
How similar studies have performed: While this approach is novel in its specific focus on screening for PH in ILD patients, similar studies have shown success in identifying pulmonary hypertension in other patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 41 other locations
- Pulmonary Associates — Phoenix, Arizona, United States (RECRUITING)
- Hartford Hospital — Hartford, Connecticut, United States (RECRUITING)
- Lakeland Regional Health — Lakeland, Florida, United States (RECRUITING)
- NCH Healthcare System — Naples, Florida, United States (RECRUITING)
- University of South Florida Health — Tampa, Florida, United States (RECRUITING)
- Cleveland Clinic Florida — Weston, Florida, United States (RECRUITING)
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
- Piedmont Healthcare — Austell, Georgia, United States (RECRUITING)
- Loyola University Chicago — Chicago, Illinois, United States (RECRUITING)
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
- NorthShore University Health System — Glenview, Illinois, United States (RECRUITING)
- University of Kentucky Medical Center — Lexington, Kentucky, United States (RECRUITING)
- LSU Health Sciences Center New Orleans — New Orleans, Louisiana, United States (RECRUITING)
- University of Michigan Int Med Pulmonary and Critical Care — Ann Arbor, Michigan, United States (RECRUITING)
- Mclaren Greater Lansing — Okemos, Michigan, United States (RECRUITING)
- Blessing Health Hannibal — Hannibal, Missouri, United States (RECRUITING)
- Renown Regional Medical Center — Reno, Nevada, United States (RECRUITING)
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)
- Jersey Shore University Medical Center — Neptune, New Jersey, United States (RECRUITING)
- Montefiore Medical Center — Bronx, New York, United States (RECRUITING)
- NYU Langone Medical Center — New York, New York, United States (RECRUITING)
- Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
- Pulmonix, LLC — Greensboro, North Carolina, United States (RECRUITING)
- East Carolina University — Greenville, North Carolina, United States (RECRUITING)
- Legacy Health — Portland, Oregon, United States (RECRUITING)
- St. Luke's University Health Network — Bethlehem, Pennsylvania, United States (RECRUITING)
- AnMed Health Pulmonary and Sleep Medicine — Anderson, South Carolina, United States (RECRUITING)
- Prisma Health — Columbia, South Carolina, United States (RECRUITING)
- StatCare Pulmonary Consultants — Knoxville, Tennessee, United States (RECRUITING)
- Premier Pulmonary Critical Care and Sleep Medicine — Denison, Texas, United States (RECRUITING)
- Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
- The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (RECRUITING)
- Intermountain Healthcare — Murray, Utah, United States (RECRUITING)
- University of Utah Health — Salt Lake City, Utah, United States (RECRUITING)
- The University of Vermont Medical Center — Burlington, Vermont, United States (RECRUITING)
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
- Inova Fairfax Hospital — Falls Church, Virginia, United States (RECRUITING)
- Sentara Cardiovascular Research Institute — Norfolk, Virginia, United States (RECRUITING)
- Pulmonary Associates of Richmond — Richmond, Virginia, United States (RECRUITING)
- Providence Medical Research Center — Spokane, Washington, United States (COMPLETED)
- Marshall Health — Huntington, West Virginia, United States (RECRUITING)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)
Study contacts
- Study coordinator: United Therapeutics Global Medical Information
- Email: clinicaltrials@unither.com
- Phone: 919-485-8350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Interstitial Lung Disease, Pulmonary Hypertension, ILD, PH, PH-ILD