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

Part of paid clinical trials in Paramus, New Jersey.

Sponsor
Valley Health System
Study ID
NCT07837830
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 24, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Inhaled Treprostinil Plus Standard of Care
    Participants receive inhaled treprostinil (Tyvaso) in addition to standard disease-specific care.
  • Active Comparator: Standard of Care
    Participants receive standard disease-specific care without inhaled treprostinil

Primary Outcome Measure

Change in Exercise Pulmonary Vascular Resistance (PVR) [ Time Frame: Baseline to Month 6 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Valley HospitalParamusNew Jersey07652
Ashish Rai, MD
[email protected]
201-447-8019
Emma Goebel, APN
[email protected]
2014478019
Ashish Rai, MD (PRINCIPAL_INVESTIGATOR)
Valley Medical Group Pulmonary Hypertension ClinicParamusNew Jersey07652-

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By research site
The Valley Hospital· Paramus, NJValley Medical Group Pulmonary Hypertension Clinic· Paramus, NJ

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