Early treatment with inhaled treprostinil for exercise-induced pulmonary hypertension in ILD or CTD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective open-label pilot study with a matched-control design to see if early inhaled treprostinil improves exercise pulmonary vascular resistance and cardiopulmonary function in patients with interstitial lung disease or connective tissue disease who have exercise-induced pulmonary hypertension. Participants receive inhaled treprostinil plus standard care or standard care alone and are followed for 6 months, with an optional extension to 12 months. Primary outcomes focus on exercise PVR at 6 months, with secondary endpoints including other hemodynamic measures, 6-minute walk distance, dyspnea scores, safety, and potential progression to resting PH at 12 months. The trial aims to determine if early treatment preserves exercise capacity and delays resting PH progression. Lead sponsor is Valley Health System, with sites in Paramus, New Jersey.

Why it matters

Who can join: the full rules

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

Where it's running

• The Valley Hospital
  Paramus, New Jersey, United States Recruiting
• Valley Medical Group Pulmonary Hypertension Clinic
  Paramus, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Ashish Rai Rai, MD — Valley Health System
• Study coordinator: Ashish Rai, MD
• Email: Raias@valleyhealth.com
• Phone: 201-447-8019

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.