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

Conditions

• Interstitial Lung Disease
• Pulmonary Hypertension
• Pulmonary Hypertension Due to Lung Diseases and Hypoxia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Prospective study assessments — OTHER
  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.

Study Details

This is a prospective, real world, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and interstitial lung disease (ILD).

Key Dates

Start date

Jan 23, 2025

Status verified

Mar 2026

Primary completion

Sep 1, 2030

Completion

Nov 30, 2030

Study Design

Enrollment

900 participants (estimated)

Arms

• Arm: Cohort 1
  Cohort 1 will include approximately 200 patients who are not receiving inhaled treprostinil at time of study enrollment.
• Arm: Cohort 2
  Cohort 2 will include approximately 300 patients who are newly initiated on Tyvaso/Tyvaso DPI. For patients to be eligible for Cohort 2, they must have initiated Tyvaso/Tyvaso DPI at Baseline or ≤ 90 days prior to Baseline.
• Arm: Cohort 3
  Cohort 3 will include approximately 300 patients who have been receiving Tyvaso/Tyvaso DPI for \> 90 days prior to Baseline.
• Arm: Cohort 4
  Cohort 4 will include approximately 100 ILD patients with a prior RHC not meeting the definition of PH but has a pulmonary artery wedge pressure ≤ 15 mmHg.

Primary Outcome Measure

Baseline characteristics as described by demographics, medical history, ILD history, PH history, family history (comorbidities), and diagnostic right heart catheterization values. [ Time Frame: Baseline ]

Central Contacts

• United Therapeutics Global Medical Information
  919-485-8350
  [email protected]

Locations (66)

Find similar trials in Birmingham, AL

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