Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection

Launched by UNITED THERAPEUTICS · Mar 16, 2023

Keywords

ClinConnect Summary

This clinical trial, called GMS-PH-001, is looking at how to better screen for pulmonary hypertension (PH) in patients who have interstitial lung disease (ILD). The goal is to find PH earlier in patients with ILD, which could help with better treatment options. This study is currently recruiting participants aged 65 to 74, and both men and women can join. To be eligible, you need to have a confirmed diagnosis of ILD, which can include various types like idiopathic pulmonary fibrosis or scleroderma-related ILD, and you must show at least two signs or symptoms that suggest you may have PH.

If you decide to participate, you will be involved in a study that helps researchers understand how to identify PH sooner in patients with ILD. You will need to give your consent to take part, and there are some criteria that could exclude you from joining, such as having a previous diagnosis of PH or certain heart conditions. Overall, your involvement could contribute to important findings that may improve care for future patients facing similar health challenges.

Gender

ALL

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).