Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

Back to homepage
MyChart

NCT06388421

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

Official Title:

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

Summary

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

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.

Disease(s) and\or Condition(s)

Pulmonary Hypertension Due to Lung Diseases and Hypoxia

Pulmonary Hypertension

Interstitial Lung Disease

Primary Purpose
Intervention/Treatment
    • Type: OTHER
    • Name: Prospective study assessments
    • Description: 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.
    • Arm Group Labels: Cohort 1, Cohort 2, Cohort 3
Sponsor
  • United Therapeutics