NCT07837830 · Valley Health System
Early Intervention With Inhaled Treprostinil Among Patients With Exercise-Induced Pulmonary Hypertension (EPIH)
(EPIH IIT)
What this study is about
This forward-looking where both patients and doctors know the treatment given 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.
View original scientific description
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.
Interventions
DRUG
Treprostinil
Description: * Initial dose 18 mcg four times daily * Titrated to 54-72 mcg four times daily as tolerated Standard disease-specific therapy continues
OTHER
Standard of Care
Standard management of ILD/CTD without treprostinil.
Primary outcome measures
Change in Exercise Pulmonary Vascular Resistance (PVR)
Time frame: Baseline to Month 6
Change in exercise pulmonary vascular resistance (PVR) from baseline to Month 6, measured during exercise right heart catheterization with invasive cardiopulmonary exercise testing (iCPET). The primary analysis will compare the change in exercise PVR between the inhaled treprostinil and standard-of-care groups
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥18 years
- ILD diagnosis or CTD diagnosis
- WHO Functional Class II-III
- Resting RHC:
- mPAP ≤20 mmHg
- PAWP ≤15 mmHg
- Exercise-induced pulmonary hypertension on iCPET
- Able to provide informed consent
Exclusion criteria
- Resting pulmonary hypertension
- Significant left heart disease
- 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
Where
- Paramus, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2026 · Source of record for eligibility and locations