RecruitingNCT05776225
Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection
Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection (PHINDER)
Sponsor
United Therapeutics
Enrollment
300 participants
Start Date
Aug 11, 2023
Study Type
OBSERVATIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- 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.
- Patients with a diagnosis of ILD based on computed tomography imaging, including:
- Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis
- Connective tissue disease-associated ILD with forced vital capacity (FVC) \<70%
- Hypersensitivity pneumonitis
- Scleroderma-related ILD
- Autoimmune ILD
- Nonspecific interstitial pneumonia
- Occupational lung disease
- Combined pulmonary fibrosis and emphysema with mild emphysema on lung imaging as determined by the Investigator
- Patients must have at least 2 signs or symptoms suggestive of PH, as specified by the study protocol.
Exclusion Criteria7
- Prior RHC with mPAP \>20 mmHg.
- Currently on a Food and Drug Administration (FDA)-approved pulmonary arterial hypertension (PAH) medication for the treatment of PAH.
- Diagnosed with chronic obstructive pulmonary disease (CPFE with mild emphysema notwithstanding).
- Uncontrolled or untreated moderate to severe sleep apnea as determined by the patient's physician.
- Pulmonary embolism within the past 3 months.
- 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.
- 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).
Interventions
PROCEDURERight heart catheterization (RHC)
RHC to evaluate pulmonary hemodynamics
Locations(42)
View Full Details on ClinicalTrials.gov
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NCT05776225
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