Pulmonary Hypertension Clinical Trial
Official title:
DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
This is a prospective, non-interventional, multicenter, registry of patients with pulmonary associated with interstitial lung disease (PH-ILD).
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | November 30, 2030 |
Est. primary completion date | August 1, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
United Therapeutics |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline characteristics as described by demographics, medical history, ILD history, PH history, family history (comorbidities), and diagnostic right heart catheterization values | Baseline | ||
Secondary | Changes in clinical features relating to patients' interstitial lung disease and pulmonary hypertension | Followed prospectively for a maximum of 5 years from date of enrollment into the registry |
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