Trials / Completed
CompletedNCT05564637
A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary Hypertension
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treprostinil | 30mcg (5 breaths) of inhaled treprostinil will be administered during the RHC procedure and patients will be initiated on outpatient inhaled treprostinil therapy for 3-months with gradual up titration to target dose as per standard clinical practice. |
| DIAGNOSTIC_TEST | Right Heart Catheterization (RHC) while exercising | A procedure to measure how well or poorly your heart is pumping and to measure the pressures in the heart and lungs. A catheter will be inserted into a vein and artery in order to take the measurements and this will be conducted while exercising on a supine cycle ergometer. Various measurements will be taken during periods of rest and exercise. |
| DIAGNOSTIC_TEST | Optional Muscle Biopsy | A sample of muscle tissue will be collected and analyzed for the ability of the cells to utilize oxygen. |
Timeline
- Start date
- 2023-03-13
- Primary completion
- 2024-10-30
- Completion
- 2024-10-30
- First posted
- 2022-10-03
- Last updated
- 2025-12-03
- Results posted
- 2025-12-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05564637. Inclusion in this directory is not an endorsement.