RecruitingPhase not listed

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This patient registry will follow patients for up to 5 years after enrollment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects health information over time from adults with interstitial lung disease (ILD), which causes lung scarring. It includes people with and without pulmonary hypertension (PH), or high blood pressure in the lungs. It is a patient registry, not a test of a new treatment.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 18 or older.
  • A detailed CT scan must show ILD with lung scarring. If you also have emphysema, the study doctor must find more scarring than emphysema on the scan.
  • For groups 1–3, a right-heart catheter test must confirm PH. This test measures heart and lung blood pressures. Required results are mean lung artery pressure above 20 mmHg, wedge pressure at or below 15 mmHg, and lung blood vessel resistance above 2 WU.
  • For group 1, you must not be taking inhaled treprostinil at the start of the study.
  • For group 2, you must start Tyvaso or Tyvaso DPI at the study start or have started it within the 90 days before.
  • For group 3, you must be taking Tyvaso or Tyvaso DPI at the study start and have started it more than 90 days before.
  • For group 4, an earlier right-heart catheter test must not meet the PH limits listed for groups 1–3. Wedge pressure must be at or below 15 mmHg.
  • You must be willing and able to give informed consent and complete surveys in English or Spanish. You may also take part in other studies.

Who can't join

  • You have confirmed PH in group 1, 2, 4, or 5, which are other types of PH. The study doctor may allow you to join if ILD is the main cause of your PH.
  • You have group 3 PH caused by a lung disease or low oxygen other than ILD with scarring.
  • You are taking inhaled treprostinil called Yutrepia at the study start. Other PH treatments are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Adults aged 18 years or older 2. Diagnosis of fibrotic ILD based on high-resolution computed tomography imaging, including but not limited to: 1. Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis 2. Autoimmune ILD 3. Chronic hypersensitivity pneumonitis 4. Nonspecific interstitial pneumonia 5. Occupational lung disease 6. Combined pulmonary fibrosis and emphysema with fibrosis greater than the extent of emphysema on lung imaging as determined by the Investigator 3. For patients to be eligible for Cohorts 1 to 3: RHC confirmed PH (mean pulmonary artery pressure \>20 mmHg, pulmonary artery wedge pressure ≤15 mmHg, pulmonary vascular resistance \>2 WU). 4. For patients to be eligible for Cohort 1, they must not be receiving inhaled treprostinil at Baseline. 5. 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. ≤90 days prior to Baseline 6. For patients to be eligible for Cohort 3, they must be receiving Tyvaso/Tyvaso DPI at Baseline and for \>90 days prior to Baseline. 7. For patients to be eligible for Cohort 4: Prior RHC not meeting the definition of PH as described in Inclusion Criterion 3 but has a pulmonary artery wedge pressure ≤15 mmHg. 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 a. In cases in which a patient has a diagnosis of PH-ILD along with a concomitant diagnosis of another PH group (eg, Group 1), enrollment may be permitted at the Investigator's discretion if, in their clinical judgment, PH-ILD is the predominant driver of the patient's PH. 2. Confirmed diagnosis of Group 3 PH associated with lung diseases and or hypoxia other than fibrotic ILD, as outlined in Inclusion Criterion 2. 3. Patients receiving inhaled treprostinil (Yutrepia™) at Baseline. Patients receiving other forms of PH therapy will be eligible for enrollment.

Study sites (70)

AL

AZ

CA

CO

DC

FL

GA

IL

IN

KS

KY

LA

MD

MI

MN

MO

NC

NH

NJ

NM

NY

OH

OK

OR

PA

SC

TN

TX

UT

VA

WI

WV