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A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Purpose

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

Pulmonary Arterial Hypertension
Interstitial Lung Disease
Healthy Adults

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Other Healthy Volunteers	Healthy volunteers will undergo RHC while exercising and an optional muscle biopsy.	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.
Experimental PAH-ILD Patients	Patients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy.	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.

Recruiting Locations

More Details

NCT ID: NCT05564637
Status: Enrolling by invitation
Sponsor: Mayo Clinic

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.