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A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Primary Purpose

Pulmonary Arterial Hypertension, Interstitial Lung Disease, Healthy Adults

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Treprostinil
Right Heart Catheterization (RHC) while exercising
Optional Muscle Biopsy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ≥ 18 Years of Age
  • Patients with suspected Pulmonary Arterial Hypertension related to Interstitial Lung Disease (ILD-PAH) undergoing right heart catheterization.
  • Undergoing cardiac catheterization for clinical indications at Mayo Clinic Rochester over a 12-month period.
  • Healthy volunteers will have no known lung disease, heart failure, muscular disease or pulmonary hypertension

Exclusion Criteria:

  • < 18 years old.

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Healthy Volunteers

PAH-ILD Patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in cardiac output reserve (Qc)
Cardiac output reserve (Qc) will be measured using the direct Fick method (L/min) during the RHC procedure.

Secondary Outcome Measures

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.
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.
Change in resting pulmonary vascular resistance
Resting pulmonary vascular resistance will be measured in Wood units (mm Hg/L/min) during the RHC procedure
Change in exercise pulmonary vascular resistance
Exercise pulmonary vascular resistance will be measured in Wood units (mm Hg/L/min) during the RHC procedure
Change in resting pulmonary artery pressure
Resting pulmonary artery pressure (mmHg) will be measured during the RHC procedure
Change in exercise pulmonary artery pressure
Exercise Pulmonary artery pressure (mmHg) will be measured during the RHC procedure
Change in resting right atrial pressure
Resting right atrial pressure (mmHg) will be measured during the RHC procedure
Change in exercise right atrial pressure
Exercise right atrial pressure (mmHg) will be measured during the RHC procedure

Full Information

First Posted
September 28, 2022
Last Updated
April 17, 2023
Sponsor
Mayo Clinic
Collaborators
United Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05564637
Brief Title
A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
Official Title
Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
United Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Interstitial Lung Disease, Healthy Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
Healthy volunteers will undergo RHC while exercising and an optional muscle biopsy.
Arm Title
PAH-ILD Patients
Arm Type
Experimental
Arm Description
Patients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy.
Intervention Type
Drug
Intervention Name(s)
Treprostinil
Intervention Description
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
Diagnostic Test
Intervention Name(s)
Right Heart Catheterization (RHC) while exercising
Intervention Description
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
Intervention Name(s)
Optional Muscle Biopsy
Intervention Description
A sample of muscle tissue will be collected and analyzed for the ability of the cells to utilize oxygen.
Primary Outcome Measure Information:
Title
Change in cardiac output reserve (Qc)
Description
Cardiac output reserve (Qc) will be measured using the direct Fick method (L/min) during the RHC procedure.
Time Frame
Baseline, approximately 35 minutes
Secondary Outcome Measure Information:
Title
Change in ventilatory efficiency (VE/VCO2)
Description
Ventilatory efficiency will be assessed as a ratio between the ventilation (VE) and carbon dioxide production (VCO2) measured during the RHC procedure.
Time Frame
Baseline, approximately 35 minutes
Title
Change in New York Heart Association (NYHA) functional class
Description
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.
Time Frame
Baseline, 3-months
Title
Change in resting pulmonary vascular resistance
Description
Resting pulmonary vascular resistance will be measured in Wood units (mm Hg/L/min) during the RHC procedure
Time Frame
Baseline; after 30 minutes of rest
Title
Change in exercise pulmonary vascular resistance
Description
Exercise pulmonary vascular resistance will be measured in Wood units (mm Hg/L/min) during the RHC procedure
Time Frame
Baseline; approximately 35 minutes
Title
Change in resting pulmonary artery pressure
Description
Resting pulmonary artery pressure (mmHg) will be measured during the RHC procedure
Time Frame
Baseline; after 30 minutes of rest
Title
Change in exercise pulmonary artery pressure
Description
Exercise Pulmonary artery pressure (mmHg) will be measured during the RHC procedure
Time Frame
Baseline; approximately 35 minutes
Title
Change in resting right atrial pressure
Description
Resting right atrial pressure (mmHg) will be measured during the RHC procedure
Time Frame
Baseline; after 30 minutes of rest
Title
Change in exercise right atrial pressure
Description
Exercise right atrial pressure (mmHg) will be measured during the RHC procedure
Time Frame
Baseline; approximately 35 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Irlbeck
Phone
507-266-6879
Email
Irlbeck.Colleen@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yogesh Reddy, M.B.B.S
Phone
507-284-3687
Email
Reddy.Yogesh@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yogesh N Reddy, M.B.B.S
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Irlbeck
Phone
507-266-6879
Email
Irlbeck.Colleen@mayo.edu
First Name & Middle Initial & Last Name & Degree
Yogesh Reddy, M.B.B.S
Phone
507-284-3687
Email
Reddy.Yogesh@mayo.edu
First Name & Middle Initial & Last Name & Degree
Yogesh N Reddy, M.B.B.S

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

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