Phase 2
N=24
A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
Pulmonary Arterial Hypertension · Interstitial Lung Disease · Healthy Adults
Bottom Line
View on ClinicalTrials.gov: NCT05564637 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Cardiac Output Reserve (Qc) — 3.3; 3.8 Liters/Min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Treprostinil (Drug); Right Heart Catheterization (RHC) while exercising (Diagnostic_test); Optional Muscle Biopsy (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Output Reserve (Qc) |
3.3; 3.8 | — |
| SECONDARY Ventilatory Efficiency (VE/VCO2) |
50.4; 51.2 | — |
| SECONDARY New York Heart Association (NYHA) Functional Class |
1; 9; 6; 6 | — |
| SECONDARY Resting Pulmonary Vascular Resistance |
5.4; 3.1 | — |
| SECONDARY Exercise Pulmonary Vascular Resistance |
4.3; 2.2 | — |
| SECONDARY Resting Pulmonary Artery Pressure |
36.0; 25.1 | — |
| SECONDARY Exercise Pulmonary Artery Pressure |
50.4; 40.6 | — |
| SECONDARY Resting Right Atrial Pressure |
7.9; 6.2 | — |
| SECONDARY Exercise Right Atrial Pressure |
16.1; 12.9 | — |
Summary
The purpose of this research study is to find out more about the drug treprostinil via inhaler and the mechanisms of why patients with pulmonary arterial hypertension related to Interstitial Lung disease (PAH-ILD) have limitations during exercise. The investigator is studying treprostinil's effect on patients with PAH-ILD during exercise and its effect on their quality of life after using it for 3 months.
Eligibility Criteria
Inclusion Criteria
- Patients with Pulmonary Arterial Hypertension due to Interstitial Lung Disease (ILD-PAH) being considered for inhaled treprostinil
- Resting right heart catheterization with mean pulmonary artery pressure >20 mmHg and PVR> 3 Wood units
- Healthy volunteers will have no known lung disease, heart failure, muscular disease or pulmonary hypertension, no bleeding abnormalities, and have the ability to exercise.
Exclusion Criteria
- Inability to exercise
- Females who are pregnant
Data sourced from ClinicalTrials.gov (NCT05564637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.