RightFit
RecruitingEarly Phase 1

Early Intervention With Inhaled Treprostinil Among Patients With Exercise-Induced Pulmonary Hypertension (EPIH)

Early Intervention With Inhaled Treprostinil Among Patients With Exercise-Induced Pulmonary Hypertension: A Prospective Open-Label Matched Control Pilot Trial.

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: 6 months

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
  • "Participants will receive inhaled treprostinil plus standard care or standard care alone and will be followed for 6 months, with an optional extension to 12 months."
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 tests whether inhaled treprostinil lowers resistance to blood flow in the lungs during exercise and helps people be more active. It is for adults with interstitial lung disease or connective tissue disease whose lung blood pressure rises during exercise. The study compares the drug plus usual care with usual care alone for 6 months, with an option to continue to 12 months.

This prospective open-label matched-control pilot study evaluates whether inhaled treprostinil improves exercise pulmonary vascular resistance and functional outcomes in adults with interstitial lung disease or connective tissue disease and exercise-induced pulmonary hypertension. Participants will receive inhaled treprostinil plus standard care or standard care alone and will be followed for 6 months, with an optional extension to 12 months.

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

Eligibility

Who can join

  • Age 18 or older.
  • Have interstitial lung disease (a group of lung disorders) or connective tissue disease (a disease affecting tissues that support the body).
  • Have WHO Functional Class II–III symptoms, meaning physical activity is somewhat or greatly limited.
  • A right heart catheter test at rest shows average lung artery pressure of 20 mmHg or less.
  • The same test shows resistance to blood flow through the lungs of 2 Wood units or less.
  • The same test shows lung artery wedge pressure, a measure related to pressure on the left side of the heart, of 15 mmHg or less.
  • Have high lung blood pressure during an exercise test that uses a catheter to measure heart and lung pressures.
  • Able to understand the study and agree to take part.

Who can't join

  • Have high lung blood pressure at rest.
  • Have major disease on the left side of the heart.
  • Have high lung blood pressure caused by long-term blood clots, or had a sudden blood clot in the lungs within the past 6 months.
  • Currently take medicine aimed at treating pulmonary arterial hypertension, a type of high lung blood pressure.
  • Are pregnant or breastfeeding.
  • Have severe kidney or liver problems.
  • Cannot do exercise testing, or cannot safely have a right heart catheter test.
  • Are allergic to treprostinil.

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

Official eligibility criteria

Inclusion Criteria: * Age ≥18 years * ILD diagnosis or CTD diagnosis * WHO Functional Class II-III * Resting RHC: * mPAP ≤20 mmHg * PVR ≤2 WU * PAWP ≤15 mmHg * Exercise-induced pulmonary hypertension on iCPET * Able to provide informed consent Exclusion Criteria: * Resting pulmonary hypertension * Significant left heart disease * CTEPH * Acute PE within 6 months * Current PAH-targeted therapy * Pregnancy or breastfeeding * Severe renal or hepatic impairment * Inability to perform exercise testing * Contraindication to RHC * Treprostinil hypersensitivity

Study sites (2)

NJ