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| Name | Class |
|---|---|
| United Therapeutics | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Other | Healthy volunteers will undergo RHC while exercising and an optional muscle biopsy. |
|
| PAH-ILD Patients | Experimental | Patients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output Reserve (Qc) | 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). | Baseline, approximately 35 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilatory Efficiency (VE/VCO2) | 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. | Baseline, approximately 35 minutes |
| New York Heart Association (NYHA) Functional Class |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yogesh N Reddy, M.B.B.S | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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29 subjects were consented of which 5 screen failed prior to study group assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | Healthy volunteers will undergo RHC while exercising and an optional muscle biopsy. 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. |
| FG001 | PAH-ILD Patients | Patients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description |
|---|---|---|
| BG000 | PAH-ILD Patients | Patients diagnosed with PAH-ILD underwent RHC while exercising, received inhaled treprostinil, and underwent an optional muscle biopsy. Treprostinil: 30mcg (5 breaths) of inhaled treprostinil was administered during the RHC procedure and patients were 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: A procedure to measure how well or poorly your heart is pumping and to measure the pressures in the heart and lungs. A catheter was inserted into a vein and artery in order to take the measurements and this was conducted while exercising on a supine cycle ergometer. Various measurements were taken during periods of rest and exercise. Optional Muscle Biopsy: A sample of muscle tissue were collected and analyzed for the ability of the cells to utilize oxygen. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cardiac Output Reserve (Qc) | 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). | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Posted | Mean | Standard Deviation | Liters/Min | Baseline, approximately 35 minutes |
|
Major procedural complications were collected from the time of informed consent through study completion, approximately 4 months.
Adverse event definition used in this study: Major procedural complications were reported through the data collection form and were monitored and adjudicated by the PI. Adverse events were not separately reported to the IRB. The drug inhaled treprostinil represents standard of care therapy for PAH-ILD and the acute administration should post no additional risk compared to the chronic therapy that was subsequently administered at an even higher dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | Healthy volunteers underwent RHC while exercising and an optional muscle biopsy. 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 was inserted into a vein and artery in order to take the measurements and this was conducted while exercising on a supine cycle ergometer. Various measurements were taken during periods of rest and exercise. Optional Muscle Biopsy: A sample of muscle tissue was collected and analyzed for the ability of the cells to utilize oxygen. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yogesh Reddy, M.B.B.S. | Mayo Clinic | 507-284-2904 | reddy.yogesh@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2024 | Oct 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C427248 | treprostinil |
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| 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. |
|
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. |
| Baseline, 3-months |
| Resting Pulmonary Vascular Resistance | 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. | Baseline; after 30 minutes of rest |
| Exercise Pulmonary Vascular Resistance | Exercise pulmonary vascular resistance was measured in Wood units (mm Hg/L/min) during the RHC procedure. | Baseline; approximately 35 minutes |
| Resting Pulmonary Artery Pressure | 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. | Baseline; after 30 minutes of rest |
| Exercise Pulmonary Artery Pressure | 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. | Baseline; approximately 35 minutes |
| Resting Right Atrial Pressure | 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. | Baseline; after 30 minutes of rest |
| Exercise Right Atrial Pressure | 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. | Baseline; approximately 35 minutes |
| BG001 | Healthy Volunteers | Healthy volunteers underwent RHC while exercising and an optional muscle biopsy. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Healthy Volunteers | Healthy volunteers underwent RHC while exercising and an optional muscle biopsy. |
|
|
| Secondary | Ventilatory Efficiency (VE/VCO2) | 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. | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Posted | Mean | Standard Deviation | Ratio | Baseline, approximately 35 minutes |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Class | 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. | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Posted | Count of Participants | Participants | Baseline, 3-months |
|
|
|
| Secondary | Resting Pulmonary Vascular Resistance | 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. | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Posted | Mean | Standard Deviation | mm Hg/L/min | Baseline; after 30 minutes of rest |
|
|
|
| Secondary | Exercise Pulmonary Vascular Resistance | Exercise pulmonary vascular resistance was measured in Wood units (mm Hg/L/min) during the RHC procedure. | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Posted | Mean | Standard Deviation | mm Hg/L/min | Baseline; approximately 35 minutes |
|
|
|
| Secondary | Resting Pulmonary Artery Pressure | 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. | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Posted | Mean | Standard Deviation | mmHg | Baseline; after 30 minutes of rest |
|
|
|
| Secondary | Exercise Pulmonary Artery Pressure | 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. | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Posted | Mean | Standard Deviation | mmHg | Baseline; approximately 35 minutes |
|
|
|
| Secondary | Resting Right Atrial Pressure | 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. | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Posted | Mean | Standard Deviation | mmHg | Baseline; after 30 minutes of rest |
|
|
|
| Secondary | Exercise Right Atrial Pressure | 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. | Only 1 participant was enrolled in the healthy volunteers arm. Based on the low enrollment number in the healthy volunteers arm, no data is reported for the 1 subject in order to protect and maintain participant privacy/confidentiality. | Posted | Mean | Standard Deviation | mmHg | Baseline; approximately 35 minutes |
|
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | PAH-ILD Patients | Patients diagnosed with PAH-ILD underwent RHC while exercising, received inhaled treprostinil, and underwent an optional muscle biopsy. Treprostinil: 30mcg (5 breaths) of inhaled treprostinil was administered during the RHC procedure and patients were 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: A procedure to measure how well or poorly your heart is pumping and to measure the pressures in the heart and lungs. A catheter was inserted into a vein and artery in order to take the measurements and this was conducted while exercising on a supine cycle ergometer. Various measurements were taken during periods of rest and exercise. Optional Muscle Biopsy: A sample of muscle tissue were collected and analyzed for the ability of the cells to utilize oxygen. | 0 | 23 | 0 | 23 | 0 | 23 |
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| Title | Measurements |
|---|
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| NYHA IV |
|