A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2024-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension Interstitial Lung Disease Healthy Adults

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

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

Group Type OTHER

Right Heart Catheterization (RHC) while exercising

Intervention Type DIAGNOSTIC_TEST

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.

Optional Muscle Biopsy

Intervention Type DIAGNOSTIC_TEST

A sample of muscle tissue will be collected and analyzed for the ability of the cells to utilize oxygen.

PAH-ILD Patients

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

Group Type EXPERIMENTAL

Treprostinil

Intervention Type DRUG

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.

Right Heart Catheterization (RHC) while exercising

Intervention Type DIAGNOSTIC_TEST

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.

Optional Muscle Biopsy

Intervention Type DIAGNOSTIC_TEST

A sample of muscle tissue will be collected and analyzed for the ability of the cells to utilize oxygen.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DIAGNOSTIC_TEST

Optional Muscle Biopsy

A sample of muscle tissue will be collected and analyzed for the ability of the cells to utilize oxygen.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.