Pulmonary HypertensionEarly Phase 1NCT07116681
Effects of Inhaled Treprostinil on Exercise Performance in Exercise Induced Pulmonary Hypertension
A Early Phase 1 study testing Inhaled treprostinil in people with Pulmonary Hypertension, run by University of California, San Diego.
Trial summary
This study aims to investigate therapies for exercise induced pulmonary hypertension (EiPH). This is a condition that effects the blood vessels in the lungs and causes shortness of breath with activity. Currently, there are very limited treatment options for this condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Inhaled treprostinil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Jul 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 18 years of older
- Established diagnosis of exercise induced pulmonary hypertension defined by the following:
- Invasive cardiopulmonary exercise testing demonstrating a mean pulmonary artery pressure to cardiac output (P/Q slope) greater than 3 mmHg/L/min
- Symptoms of exertional dyspnea
- Ability to perform non-invasive cardiopulmonary exercise testing, either on upright bicycle or treadmill
- If childbearing age, patient must agree to use of effective contraception during the trial
Who cannot join
- Diagnosis of pulmonary hypertension as defined by resting mean pulmonary arterial pressure of ≥ 20 mmHg, PVR > 3
- Severe underlying chronic lung disease (e.g. COPD, interstitial lung disease)
- Underlying chronic left ventricular disease (e.g. heart failure with reduced ejection fraction)
- Chronic thromboembolic disease
- Pregnancy
- Acute infectious symptoms including fevers within the last week
Show all 9Show fewer
- Inability or unwillingness to discontinue any phosphodiesterase 5 inhibitors or other off-label
- Known allergic reactions to inhaled treprostinil
- Inability to comply with study protocols
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Acute Effects of Dry Powder Inhaled Treprostinil on Stroke Volume Augmentation and Dead Space Ventilation in Patients With Exercise-induced Pulmonary Hypertension
This study aims to investigate therapies for exercise induced pulmonary hypertension (EiPH). This is a condition that effects the blood vessels in the lungs and causes shortness of breath with activity. Currently, there are very limited treatment options for this condition. Inhaled treprostinil, also known as Tyvaso, is a medication used to treat other forms of lung disease and is safe and well tolerated. This study will measure the ability of Tyvaso to improve symptoms related to EiPH and improve performance on exercise testing.
Read the detailed description
Exercise-induced pulmonary hypertension (EiPH) is defined by the presence of normal resting pulmonary hemodynamics with an abnormal elevation in mean pulmonary artery pressure (mPAP) for a given cardiac output with exercise. EiPH is typically characterized by exertional dyspnea, with the absence of other features of resting pulmonary arterial hypertension (PAH) such as elevated right atrial pressure at rest or lower extremity peripheral edema. Since patients with EiPH have normal resting echocardiograms, the disease is often underdiagnosed. Exercise right-heart catheterization remains the gold standard in diagnosing EiPH.
Aside from subjective markers of clinical improvement with therapy, assessment for physiological improvement is challenging since most measures of PAH severity, including echocardiograms, biomarkers and risk calculators, are normal at baseline in this population with EiPH. The investigators have pioneered the use of non-invasive cardiopulmonary exercise testing (CPET) to assess patients with cardiopulmonary limitations during exercise. Changes in oxygen pulse (O2 pulse) during exercise on CPET have previously been validated as an accurate predictor of stroke volume augmentation, which is an important physiological adaptation to exercise, and may serve as an objective marker of improvement in patients with EiPH.
While the guidelines agree that EiPH is real and under-diagnosed, there is no consensus on the management since these patients have not been included in high-quality clinical trials for PAH treatment. Given the lack of treatment guidelines for EiPH, many providers use PAH-targeted therapy off-label in EiPH. Specifically, generic phosphodiesterase-5 inhibitors are the typical first line agent due to insurance barriers to accessing other therapies. Inhaled treprostinil (Tyvaso DPI) would be an ideal medication for this population. Tyvaso DPI is a convenient, inhaled medication with quick onset. The favorable pharmacokinetic profile raises the potential of this medication for dosing prior to exertion for patients with EiPH.
- Conditions
- Pulmonary Hypertension
- Being tested
- Inhaled treprostinil
- Keywords
- Exercise Induced Pulmonary Hypertension, Tyvaso, Inhaled treprostinil, Cardiopulmonary exercise testing
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled treprostinilDrug
Also called tyvaso
Inhaled treprostinil is an inhaled prostacyclin analog which triggers pulmonary arterial dilation. This is the only intervention in this trial.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Single arm, every participant will receive inhaled treprostinil Receives: Drug: Inhaled treprostinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume augmentation before and after inhaled treprostinil
Stroke volume augmentation is a physiologic parameter which reflects the hearts ability to respond to physiologic demands of exercise. Stroke volume can be inferred during cardiopulmonary exercise testing by calculating the O2 pulse. Oxygen uptake (VO2) and heart rate are directly measured during cardiopulmonary exercise testing. O2 pulse is calculated by dividing VO2 by heart rate. Stroke volume augmentation is the ratio of O2 pulse at baseline (at the beginning of exercise) and at anaerobic threshold. Stroke volume augmentation will be measured before and after treatment with inhaled treprostinil to assess for improvements in heart function during exercise.
Measured: 30 minutes after initial dose of inhaled treprostinil
Secondary outcomes (3)
PAH Sympact Scoring
PAH Sympact is a validated symptom assessment questionnaire, measuring patient reported outcomes related to cardiopulmonary symptoms and impact on daily life. Each domain is assessed a score from 0-4, with higher numbers representing more severe symptomatology of limitation. This questionnaire will be completed by the participants before initiation of inhaled treprostinil and after 8 weeks of therapy.
Measured: 8 weeks
Long term stroke volume augmentation
Stroke volume augmentation (see description in primary outcomes description) will be retested after 8 weeks of therapy with inhaled treprostinil
Measured: 8 weeks
Dead space ventilation
Dead space ventilation is a measure of ventilatory efficiency. This is assessed during cardiopulmonary exercise testing through continuous measurement of exhaled carbon dioxide and monitoring of tissue carbon dioxide levels. It will be measured before treatment with inhaled treprostinil, 30 minutes after the first dose of treprostinil, and again after 8 weeks of treprostinil therapy.
Measured: 30 minutes, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- United Therapeutics
- Responsible party
- Principal investigator, Timothy Fernandes, University of California, San Diego
- Investigators
- Timothy Fernandes, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116681
- Sponsor's protocol ID
- 813050
- Other IDs
- ISS-2025-0061
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients name, phone number, and medical record number will be stored with associated information regarding baseline diagnostic testing, cardiopulmonary exercise testing results, PAH-Sympact scores, and adverse event reporting
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Dry Powder Inhaled Treprostinil on Stroke Volume Augmentation and Dead Space Ventilation in Patients With Exercise-induced Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07116681
- Acronym / sponsor ID
- 813050
- Conditions
- Pulmonary Hypertension
- Keywords
- Exercise Induced Pulmonary Hypertension, Tyvaso, Inhaled treprostinil, Cardiopulmonary exercise testing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- United Therapeutics
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate therapies for exercise induced pulmonary hypertension (EiPH). This is a condition that effects the blood vessels in the lungs and causes shortness of breath with activity. Currently, there are very limited treatment options for this condition. Inhaled treprostinil, also known as Tyvaso, is a medication used to treat other forms of lung disease and is safe and well tolerated. This study will measure the ability of Tyvaso to improve symptoms related to EiPH and improve performance on exercise testing.
Detailed description
Exercise-induced pulmonary hypertension (EiPH) is defined by the presence of normal resting pulmonary hemodynamics with an abnormal elevation in mean pulmonary artery pressure (mPAP) for a given cardiac output with exercise. EiPH is typically characterized by exertional dyspnea, with the absence of other features of resting pulmonary arterial hypertension (PAH) such as elevated right atrial pressure at rest or lower extremity peripheral edema. Since patients with EiPH have normal resting echocardiograms, the disease is often underdiagnosed. Exercise right-heart catheterization remains the gold standard in diagnosing EiPH.
Aside from subjective markers of clinical improvement with therapy, assessment for physiological improvement is challenging since most measures of PAH severity, including echocardiograms, biomarkers and risk calculators, are normal at baseline in this population with EiPH. The investigators have pioneered the use of non-invasive cardiopulmonary exercise testing (CPET) to assess patients with cardiopulmonary limitations during exercise. Changes in oxygen pulse (O2 pulse) during exercise on CPET have previously been validated as an accurate predictor of stroke volume augmentation, which is an important physiological adaptation to exercise, and may serve as an objective marker of improvement in patients with EiPH.
While the guidelines agree that EiPH is real and under-diagnosed, there is no consensus on the management since these patients have not been included in high-quality clinical trials for PAH treatment. Given the lack of treatment guidelines for EiPH, many providers use PAH-targeted therapy off-label in EiPH. Specifically, generic phosphodiesterase-5 inhibitors are the typical first line agent due to insurance barriers to accessing other therapies. Inhaled treprostinil (Tyvaso DPI) would be an ideal medication for this population. Tyvaso DPI is a convenient, inhaled medication with quick onset. The favorable pharmacokinetic profile raises the potential of this medication for dosing prior to exertion for patients with EiPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Inhaled treprostinilSingle arm, every participant will receive inhaled treprostinil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 18 years of older
- Established diagnosis of exercise induced pulmonary hypertension defined by the following:
- Ability to perform non-invasive cardiopulmonary exercise testing, either on upright bicycle or treadmill
Key exclusion criteria (9 listed)
- Diagnosis of pulmonary hypertension as defined by resting mean pulmonary arterial pressure of ≥ 20 mmHg, PVR > 3
- Severe underlying chronic lung disease (e.g. COPD, interstitial lung disease)
- Underlying chronic left ventricular disease (e.g. heart failure with reduced ejection fraction)
- Chronic thromboembolic disease
- Pregnancy
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 |
|---|---|---|
| Inhaled treprostinilAlso: tyvasoInhaled treprostinil is an inhaled prostacyclin analog which triggers pulmonary arterial dilation. This is the only intervention in this trial. | Drug | Treatment group |
Primary outcome
Stroke volume augmentation before and after inhaled treprostinil
Time frame: 30 minutes after initial dose of inhaled treprostinil
Stroke volume augmentation is a physiologic parameter which reflects the hearts ability to respond to physiologic demands of exercise. Stroke volume can be inferred during cardiopulmonary exercise testing by calculating the O2 pulse. Oxygen uptake (VO2) and heart rate are directly measured during cardiopulmonary exercise testing. O2 pulse is calculated by dividing VO2 by heart rate. Stroke volume augmentation is the ratio of O2 pulse at baseline (at the beginning of exercise) and at anaerobic threshold. Stroke volume augmentation will be measured before and after treatment with inhaled treprostinil to assess for improvements in heart function during exercise.
3 secondary outcomes
PAH Sympact Scoring
Time frame: 8 weeks
Long term stroke volume augmentation
Time frame: 8 weeks
Dead space ventilation
Time frame: 30 minutes, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Yes. Patients name, phone number, and medical record number will be stored with associated information regarding baseline diagnostic testing, cardiopulmonary exercise testing results, PAH-Sympact scores, and adverse event reporting
Related trials for Pulmonary Hypertension
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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.
Timothy Fernandes, MD principal investigator
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Inhaled treprostinil in people with Pulmonary Hypertension, run by University of California, San Diego.
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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew D Rockstrom, MD (15093781906, mrockstrom11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke volume augmentation before and after inhaled treprostinil (time frame: 30 minutes after initial dose of inhaled treprostinil). 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 24 Aug 2025.