Early Intervention With Inhaled Treprostinil Among Patients With Exercise-Induced Pulmonary Hypertension: A Prospective Open-Label Matched Control Pilot Trial.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
New Jersey
The Valley Hospital
RECRUITING
Paramus
Valley Medical Group Pulmonary Hypertension Clinic
RECRUITING
Paramus
Contact Information
Primary
Ashish Rai, MD
Raias@valleyhealth.com
201-447-8019
Backup
Emma Goebel, APN
nichem@Valleyhealth.com
2014478019
Time Frame
Start Date: 2026-09
Estimated Completion Date: 2028-06
Participants
Target number of participants: 32
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Valley Health System