Decipher
| Clinical Trial Title | DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) |
| Trial Status | Open to Enrollment |
| Start Date | 11/12/2024 |
| Location | pulmonary-good-sam |
| Trial Type | Pulmonary Hypertension |
| Specific Condition | Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) |
| Description | The purpose of this study is to capture and analyze patient characteristics, treatment patterns, and clinical outcomes of patients with PH-ILD, with the goal of enhancing our current understanding of the disease state and its treatment outcomes. The study also aims to describe the disease trajectory of ILD patients at risk of pulmonary hypertension (PH). In this registry, patients will be enrolled into 1 of 4 cohorts. Cohort 1 will include approximately 200 patients who are not receiving inhaled treprostinil at time of study enrollment. Cohort 2 will include approximately 300 patients who are newly initiated on Tyvaso/Tyvaso DPI. Cohort 3 will include approximately 300 patients who have been receiving Tyvaso/Tyvaso DPI for >90 days. Cohort 4 will include approximately 100 ILD patients with a prior right heart catheterization (RHC) not meeting the definition of PH. As part of the registry, assessments will be completed for data collection in 6- or 12 month intervals, unless the data are already available via standard of care. This patient registry will follow patients for up to 5 years after enrollment. |
| Eligibility Criteria | Eligibility Criteria: 1. Adults aged 18 years or older 2. Diagnosis of fibrotic ILD based on high-resolution computed tomography imaging, including but not limited to: • Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis • Autoimmune ILD • Chronic hypersensitivity pneumonitis • Nonspecific interstitial pneumonia • Occupational lung disease • Combined pulmonary fibrosis and emphysema with fibrosis greater than the extent of emphysema on lung imaging as determined by the Investigator 3. For patients to be eligible for Cohorts 1 to 3: Right Heart Cath confirmed Pulmonary Hypertension |
| IRB Number | 10903 |
| Notes | https://clinicaltrials.gov/study/NCT06388421?cond=Pulmonary%20Hypertension&term=GMS-PH-401&viewType=Card&rank=1 |
| Principal Investigator | Steven Sears, DO |
| Contact Name | Madeline Cooke |
| Contact Phone | 503-413-8330 |
| Contact Fax | 503-413-6861 |
| Contact E-Mail | macooke@lhs.org |
