Recruiting at 2 sites Early Phase 1 Pulmonary Hypertension

Pulmonary Hypertension study: Treprostinil

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

ClinicalTrials.gov ID: NCT07837830

What this study is testing

What is Treprostinil?

Treprostinil is an investigational medicine, inhaled once daily, being studied as a potential treatment for pulmonary hypertension.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study aims to find out if inhaled treprostinil lowers blood pressure in the lungs and improves how well people can exercise.
Who it's for
Adults with interstitial lung disease or connective tissue disease who have high blood pressure in the lungs when they exercise.
What's involved
Participants will receive inhaled treprostinil along with their usual care, or just their usual care, and undergo tests to check their heart and lung function.
Time commitment
The study lasts 6 months, with an optional extension to 12 months, requiring regular visits for monitoring.
  • Phase 1: an early, usually small safety study
  • Time commitment: about 6 months

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥18 years
  • ILD diagnosis or CTD diagnosis
  • WHO Functional Class II-III
  • mPAP ≤20 mmHg
  • PVR ≤2 WU

You likely can't join if

  • Resting pulmonary hypertension
  • Significant left heart disease
  • CTEPH
  • Acute PE within 6 months
  • Current PAH-targeted therapy
  • Pregnancy or breastfeeding
See the full eligibility criteria
Who can join
  • Age ≥18 years
  • ILD diagnosis or CTD diagnosis
  • WHO Functional Class II-III
  • mPAP ≤20 mmHg
  • PVR ≤2 WU
  • PAWP ≤15 mmHg
  • Exercise-induced pulmonary hypertension on iCPET
  • Able to provide informed consent
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it is enrolling

  • Paramus, New Jersey, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Paramus, New Jersey, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.