32 Participants NeededMy employer runs this trial

Inhaled Treprostinil for Pulmonary Hypertension

(EPIH IIT Trial)

Recruiting at 1 trial location
AR
EG
Overseen ByEmma Goebel, APN
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Valley Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AR

Ashish Rai Rai, MD

Principal Investigator

Valley Health System

Are You a Good Fit for This Trial?

This trial is for adults with interstitial lung disease or connective tissue disease who develop high blood pressure in the lungs during exercise. Participants should not have other major health issues that would prevent safe participation.

Inclusion Criteria

Resting RHC with PAWP ≤15 mmHg
Resting RHC with mPAP ≤20 mmHg
Resting RHC with PVR ≤2 WU
See 5 more

Exclusion Criteria

Treprostinil hypersensitivity
Pregnancy or breastfeeding
I have chronic thromboembolic pulmonary hypertension (CTEPH).
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Treprostinil

Trial Overview

The study compares inhaled treprostinil plus standard care versus standard care alone to see if it helps improve lung blood flow and physical ability. Participants are followed for at least 6 months, possibly up to a year.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Inhaled Treprostinil Plus Standard of CareExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Valley Health System

Lead Sponsor

Trials
11
Recruited
1,900+