RECRUITING

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

Conditions

Pulmonary Hypertension Due to Lung Diseases and Hypoxia Pulmonary Hypertension Interstitial Lung Disease pulmonary hypertension associated with interstitial lung disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective, non-interventional, multicenter, registry of patients with 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)

Quick Facts

Study Start:2025-01-31

Study Completion:2030-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06388421

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

United Therapeutics Global Medical Information

CONTACT

919-485-8350

clinicaltrials@unither.com

Study Locations (Sites)

AnMed Health

Anderson, South Carolina, 29621

United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23230

United States

Collaborators and Investigators

Sponsor: United Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-31

Study Completion Date2030-11-30

Study Record Updates

Study Start Date2025-01-31

Study Completion Date2030-11-30

Terms related to this study

Keywords Provided by Researchers

pulmonary hypertension
interstitial lung disease
pulmonary hypertension associated with interstitial lung disease

Additional Relevant MeSH Terms

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