DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Launched by UNITED THERAPEUTICS · Apr 24, 2024

Keywords

ClinConnect Summary

The DeciPHer-ILD clinical trial is studying a group of patients who have pulmonary hypertension (high blood pressure in the lungs) related to interstitial lung disease (a type of lung disease that affects the tissue and space around the air sacs in the lungs). This study aims to gather real-world information about how this condition affects patients and how they respond to different treatments. The trial is currently recruiting participants aged 18 and older who have been diagnosed with interstitial lung disease and have confirmed pulmonary hypertension.

To be eligible, participants must meet certain criteria, such as having a specific lung function measurement and not currently using certain treatments like inhaled treprostinil. Participants can expect to share their experiences and complete surveys, and they may be involved in different treatment groups based on their current medications. This study is important because it will help researchers understand more about how pulmonary hypertension and interstitial lung disease impact patients' lives, which could lead to better care and treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults aged 18 years or older
• • 2. Diagnosis of ILD by traditional or HRCT determined by the site/institution that conducted the HRCT
• • 3. Patients with connective tissue disease must have a baseline forced vital capacity of \<70%
• • 4. RHC confirmed PH (mean pulmonary artery pressure \>20 mmHg, pulmonary arterial wedge pressure ≤15 mmHg, pulmonary vascular resistance \>2 WU).
• • 5. For patients to be eligible for Cohort 1, they must not be receiving inhaled treprostinil at Baseline.
• 6. For patients to be eligible for Cohort 2, they must have initiated Tyvaso/Tyvaso DPI at 1 of the following time points:
• • 1. Baseline
• • 2. ≤60 days prior to Baseline
• • 7. For patients to be eligible for Cohort 3, they must be receiving Tyvaso/Tyvaso DPI at Baseline and for \>60 days prior to Baseline
• • 8. Co-enrollment in other observational or interventional studies is permitted
• • 9. Patient is willing and able to provide informed consent and complete surveys/questionnaires in English or Spanish
• Exclusion Criteria:
• • 1. Confirmed diagnosis of Group 1, 2, 4, or 5 PH
• • 2. Confirmed diagnosis of Group 3 PH related to chronic obstructive pulmonary disease or conditions that cause hypoxemia, such as untreated or inadequately treated obstructive sleep apnea and alveolar hypoventilation disorders
• • 3. Patients receiving Yutrepia (inhaled treprostinil) at Baseline.