RecruitingNCT06388421
DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Sponsor
United Therapeutics
Enrollment
1,000 participants
Start Date
Jan 23, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
This is a prospective, non-interventional, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- Adults aged 18 years or older
- Diagnosis of ILD by traditional or HRCT determined by the site/institution that conducted the HRCT
- Patients with connective tissue disease must have a baseline forced vital capacity of \<70%
- RHC confirmed PH (mean pulmonary artery pressure \>20 mmHg, pulmonary arterial wedge pressure ≤15 mmHg, pulmonary vascular resistance \>2 WU).
- For patients to be eligible for Cohort 1, they must not be receiving inhaled treprostinil at Baseline.
- For patients to be eligible for Cohort 2, they must have initiated Tyvaso/Tyvaso DPI at 1 of the following time points:
- Baseline
- ≤60 days prior to Baseline
- For patients to be eligible for Cohort 3, they must be receiving Tyvaso/Tyvaso DPI at Baseline and for \>60 days prior to Baseline
- Co-enrollment in other observational or interventional studies is permitted
- Patient is willing and able to provide informed consent and complete surveys/questionnaires in English or Spanish
Exclusion Criteria3
- Confirmed diagnosis of Group 1, 2, 4, or 5 PH
- 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
- Patients receiving Yutrepia (inhaled treprostinil) at Baseline.
Interventions
OTHERProspective study assessments
Patients will complete prospective assessments at 6- and 12-month intervals for up to 5 years. There will be 1 check in at the first 3 months of enrollment. Follow up visits will include a ±45 day visit window. If an assessment is performed within 45 days of the visit window as part of the patient's standard of care, those values will be used in place of a prospective assessment.
Locations(59)
View Full Details on ClinicalTrials.gov
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NCT06388421
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