A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Healthy Adults; Interstitial Lung Disease; Pulmonary Arterial Hypertension

Treatments: Diagnostic Test: Optional Muscle Biopsy; Diagnostic Test: Right Heart Catheterization (RHC) while exercising; Drug: Treprostinil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05564637

22-004971

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Healthy Volunteers

Other group

Description:

Healthy volunteers will undergo RHC while exercising and an optional muscle biopsy.

Treatment:

Diagnostic Test: Right Heart Catheterization (RHC) while exercising

Diagnostic Test: Optional Muscle Biopsy

PAH-ILD Patients

Experimental group

Description:

Patients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy.

Treatment:

Drug: Treprostinil

Diagnostic Test: Right Heart Catheterization (RHC) while exercising

Diagnostic Test: Optional Muscle Biopsy