Pulmonary Arterial HypertensionPhase 2NCT05564637
A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension
A Phase 2 study testing Treprostinil, Right Heart Catheterization (RHC) while exercising and Optional Muscle Biopsy in people with Pulmonary Arterial Hypertension and Interstitial Lung Disease, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension, Interstitial Lung Disease, Healthy Adults
- What is being tested?
- Treprostinil, Right Heart Catheterization (RHC) while exercising and Optional Muscle Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 30 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to exercise
- Females who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in 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.
- Being tested
- Treprostinil, Right Heart Catheterization (RHC) while exercising, Optional Muscle Biopsy
- Medical subject headings
- Pulmonary Arterial Hypertension, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreprostinilDrug
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 exercisingDiagnostic 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 BiopsyDiagnostic test
A sample of muscle tissue will be collected and analyzed for the ability of the cells to utilize oxygen.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | Healthy volunteers will undergo RHC while exercising and an optional muscle biopsy. Receives: Diagnostic Test: Right Heart Catheterization (RHC) while exercising; Diagnostic Test: 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. Receives: Drug: Treprostinil; Diagnostic Test: Right Heart Catheterization (RHC) while exercising; Diagnostic Test: Optional Muscle Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, approximately 35 minutes
Secondary outcomes (8)
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.
Measured: Baseline, approximately 35 minutes
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; approximately 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start13 Mar 2023
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- United Therapeutics
- Responsible party
- Principal investigator, Yogesh Reddy, Mayo Clinic
- Investigators
- Yogesh N Reddy, M.B.B.S, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564637
- Sponsor's protocol ID
- 22-004971
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2022
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05564637
- Acronym / sponsor ID
- 22-004971
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- United Therapeutics
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Posted 3 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | Diagnostic Test: Right Heart Catheterization (RHC) while exercising, Diagnostic Test: Optional Muscle BiopsyHealthy volunteers will undergo RHC while exercising and an optional muscle biopsy. |
| PAH-ILD Patients | Experimental | Drug: Treprostinil, Diagnostic Test: Right Heart Catheterization (RHC) while exercising, Diagnostic Test: Optional Muscle BiopsyPatients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to exercise
- Females who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treprostinil30mcg (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. | Drug | PAH-ILD Patients |
| Right Heart Catheterization (RHC) while exercisingA 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. | Diagnostic test | Healthy Volunteers, PAH-ILD Patients |
| Optional Muscle BiopsyA sample of muscle tissue will be collected and analyzed for the ability of the cells to utilize oxygen. | Diagnostic test | Healthy Volunteers, PAH-ILD Patients |
Primary outcome
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).
8 secondary outcomes
Ventilatory Efficiency (VE/VCO2)
Time frame: Baseline, approximately 35 minutes
New York Heart Association (NYHA) Functional Class
Time frame: Baseline, 3-months
Resting Pulmonary Vascular Resistance
Time frame: Baseline; after 30 minutes of rest
Exercise Pulmonary Vascular Resistance
Time frame: Baseline; approximately 35 minutes
Resting Pulmonary Artery Pressure
Time frame: Baseline; after 30 minutes of rest
Exercise Pulmonary Artery Pressure
Time frame: Baseline; approximately 35 minutes
Resting Right Atrial Pressure
Time frame: Baseline; after 30 minutes of rest
Exercise Right Atrial Pressure
Time frame: Baseline; approximately 35 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Arterial Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yogesh N Reddy, M.B.B.S principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treprostinil, Right Heart Catheterization (RHC) while exercising and Optional Muscle Biopsy in people with Pulmonary Arterial Hypertension and Interstitial Lung Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output Reserve (Qc) (time frame: Baseline, approximately 35 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.