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RECRUITING Early Phase 1 ClinicalTrials.gov

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

Sponsor: Valley Health System • ClinicalTrials.gov ID: NCT07837830

Registry updated: 2026-09-24
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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

  • Treprostinil (Drug)
    Description: * Initial dose 18 mcg four times daily * Titrated to 54-72 mcg four times daily as tolerated Standard disease-specific therapy continues
  • Standard of Care (Other)
    Standard management of ILD/CTD without treprostinil.

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

Conditions

Pulmonary Hypertension

Locations

  • The Valley Hospital — Paramus, New Jersey, United States
  • Valley Medical Group Pulmonary Hypertension Clinic — Paramus, New Jersey, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record