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NCT05564637 Clinical Trial

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05564637
Other study ID # 22-004971
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date March 13, 2023
Est. completion date June 2024

Study information
Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 24
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in cardiac output reserve (Qc) Cardiac output reserve (Qc) will be measured using the direct Fick method (L/min) during the RHC procedure. Baseline, approximately 35 minutes
Secondary Change in ventilatory efficiency (VE/VCO2) Ventilatory efficiency will be assessed as a ratio between the ventilation (VE) and carbon dioxide production (VCO2) measured during the RHC procedure. Baseline, approximately 35 minutes
Secondary Change in New York Heart Association (NYHA) functional class Patients severity of heart failure symptoms will be classified according to the NHYA functional class (I-IV). Lower classifications indicate lower severity of heart failure symptoms. Baseline, 3-months
Secondary Change in resting pulmonary vascular resistance Resting pulmonary vascular resistance will be measured in Wood units (mm Hg/L/min) during the RHC procedure Baseline; after 30 minutes of rest
Secondary Change in exercise pulmonary vascular resistance Exercise pulmonary vascular resistance will be measured in Wood units (mm Hg/L/min) during the RHC procedure Baseline; approximately 35 minutes
Secondary Change in resting pulmonary artery pressure Resting pulmonary artery pressure (mmHg) will be measured during the RHC procedure Baseline; after 30 minutes of rest
Secondary Change in exercise pulmonary artery pressure Exercise Pulmonary artery pressure (mmHg) will be measured during the RHC procedure Baseline; approximately 35 minutes
Secondary Change in resting right atrial pressure Resting right atrial pressure (mmHg) will be measured during the RHC procedure Baseline; after 30 minutes of rest
Secondary Change in exercise right atrial pressure Exercise right atrial pressure (mmHg) will be measured during the RHC procedure Baseline; approximately 35 minutes
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Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
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