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NCT Number: NCT05564637

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

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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Key information

Conditions

Pulmonary Arterial Hypertension Healthy Adults Hypertension, Pulmonary Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treprostinil

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

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

Diagnostic Test

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

Primary outcomes

  1. Cardiac Output Reserve (Qc)

    Time frame: Baseline, approximately 35 minutes

    Cardiac output reserve (Qc) is the difference between the heart's maximum output during exercise and its resting output. This was measured using the direct Fick method (L/min).

Secondary outcomes

  1. Ventilatory Efficiency (VE/VCO2)

    Time frame: Baseline, approximately 35 minutes

    Ventilatory efficiency was assessed as a ratio between the ventilation (VE) and carbon dioxide production (VCO2) measured during the RHC procedure. VE/VCO2 evaluates how efficiently a person breathes during exercise.

  2. New York Heart Association (NYHA) Functional Class

    Time frame: Baseline, 3-months

    Participants severity of heart failure symptoms was classified according to the NHYA functional class (I-IV). Lower classifications indicate lower severity of heart failure symptoms.

  3. Resting Pulmonary Vascular Resistance

    Time frame: Baseline; after 30 minutes of rest

    Resting pulmonary vascular resistance was measured in Wood units (mm Hg/L/min) during the RHC procedure. Resting pulmonary vascular resistance is the resistance against blood flow from the pulmonary veins to the left atrium of the heart.

  4. Exercise Pulmonary Vascular Resistance

    Time frame: Baseline; approximately 35 minutes

    Exercise pulmonary vascular resistance was measured in Wood units (mm Hg/L/min) during the RHC procedure.

  5. Resting Pulmonary Artery Pressure

    Time frame: Baseline; after 30 minutes of rest

    Resting pulmonary artery pressure (mmHg) was measured during the RHC procedure. Pulmonary artery pressure is the pressure within the pulmonary arteries, which transport deoxygenated blood from the right side of the heart to the lungs for oxygenation.

  6. Exercise Pulmonary Artery Pressure

    Time frame: Baseline; approximately 35 minutes

    Exercise Pulmonary artery pressure (mmHg) was measured during the RHC procedure. Pulmonary artery pressure is the pressure within the pulmonary arteries, which transport deoxygenated blood from the right side of the heart to the lungs for oxygenation.

  7. Resting Right Atrial Pressure

    Time frame: Baseline; after 30 minutes of rest

    Resting right atrial pressure (mmHg) was measured during the RHC procedure. Right atrial pressure is a measurement that reflects the amount of blood returning to the heart and the heart's ability to pump blood into the arterial system.

  8. Exercise Right Atrial Pressure

    Time frame: Baseline; approximately 35 minutes

    Exercise right atrial pressure (mmHg) was measured during the RHC procedure. Right atrial pressure is a measurement that reflects the amount of blood returning to the heart and the heart's ability to pump blood into the arterial system.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • United Therapeutics

Registry information

Official study title

Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary Hypertension

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2022
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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