Recruiting
Early Phase 1

Inhaled Treprostinil

Sponsor:

Valley Health System

Code:

NCT07837830

Conditions

Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Treprostinil

Standard of Care

Study Details

Brief summary:

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.

Conditions

Pulmonary Hypertension

Study ID

NCT07837830

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Treprostinil

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

Standard management of ILD/CTD without treprostinil.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ashish Rai, MD

201-447-8019Raias@valleyhealth.com

Emma Goebel, APN

2014478019nichem@Valleyhealth.com

Locations

The Valley Hospital

Recruiting

Paramus, New Jersey, United States, 07652

Contacts

Ashish Rai, MD

201-447-8019Raias@valleyhealth.com

Emma Goebel, APN

2014478019nichem@Valleyhealth.com

Principal Investigator:

Ashish Rai, MD

Valley Medical Group Pulmonary Hypertension Clinic

Recruiting

Paramus, New Jersey, United States, 07652

More Information

Sponsor

Valley Health System

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Pulmonary Hypertension
  • Treprostinil
  • ILD
  • Pulmonary Vascular Resistance
  • Pulmonary Vascular Disease
  • iCPET
  • Connective Tissue Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Valley Health System on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.