Obstructive Sleep ApneaPhase 2CRESCENDO-SLPNCT05237505
The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
A Phase 2 study testing bi-level positive pressure non invasive ventilation and Oxygen gas in people with Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease, run by University of California, San Diego at 1 site in United States.
Trial summary
Major progress has been made in the area of cardiovascular disease, but we believe that further progress will involve mechanistically addressing underlying respiratory causes including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Overlap Syndrome
- What is being tested?
- bi-level positive pressure non invasive ventilation and Oxygen gas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to 31 Aug 2028
- Phase
- Phase 2
- 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 40 to 79 years
- 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 40-79.
- For women, only postmenopausal women will be included
- Diagnosed with untreated moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events/hr and ≤80 events/hr) and/or diagnosed with COPD with FEV1/FVC ratio <0.7 and will be on stable medications as assessed by a board-certified pulmonologist.
Who cannot join
- Premenopausal women (i.e. women are pregnant or may become pregnant) or lactation
- Presence of specific devices: cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices, metallic foreign bodies, implantable neurostimulation systems, cochlear implants/ear implant, drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps), metallic fragments such as bullets, shotgun pellets, and metal shrapnel , cerebral artery aneurysm clips, magnetic dental implants, and artificial limb.
- Known allergic reactions to components of the study intervention: (if getting contrast, MRI contrast (gadolinium)).
- Concurrent severe sleep disorders (such as periodic limb movements, restless legs syndrome, narcolepsy, idiopathic hypersomnia, etc).
- Exhibit Cheyne-Stokes respiration or central sleep apnea (> 25 % of events central)
- Take potentially confounding medications or hormones that affect breathing.
Show all 16Show fewer
- Subjects will be excluded if they are deemed medically unstable with active neurological, cardiac, liver, endocrine, and infectious diseases.
- We will also exclude participants with pulmonary disease apart from COPD.
- We will exclude participants with active cancer treatment.
- We will exclude azotemia (estimated glomerular fraction rate < 30ml/min) as there is some concern about giving gadolinium to these patients (if getting contrast MRI).
- people with exposures deemed to be problematic for the research e.g. any smoking in bedroom by participant or household member, major second-hand smoke, e-cigarettes, tetrahydrocannabinol, major drug or alcohol consumption (>3 oz/day) and other environmental pollution effects (indoor and outdoor).
- Individuals who are already on continuous O2 for COPD or PAP treatment for OSA.
- Patients with sustained desaturations below 89% during wake time will be excluded for ethical reasons since withholding oxygen in hypoxemic patients would be at odds with standard of care.
- Individuals with OSA (AHI range 15-80/hr) will be screened for pathological sleepiness and will be excluded if ESS >18/24, history of motor vehicle accident or near miss accident, or high-risk occupation.
- COPD individuals with arterial PCO2 higher than 52 mmHg will be excluded.
- Individuals who are currently incarcerated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSD Sleep Research
La Jolla, California, 92037
Pam DeYoung, RPSGT, 858-246-2154, sleepresearch@health.ucsd.edu
Pamela DeYoung, RPSGT, 858 2462154, pdeyoung@health.ucsd.edu
About this study
Major progress has been made in the area of cardiovascular disease, but we believe that further progress will involve mechanistically addressing underlying respiratory causes including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The most common cause of death in COPD is cardiovascular, although mechanisms are unknown. OSA has been associated with major neurocognitive and cardiovascular sequelae, the latter likely a function of autonomic nervous system abnormalities, oxidative stress, inflammation, and other pathways. Recent data suggest that individuals with OVS die preferentially of cardiovascular disease compared to OSA or COPD alone, although mechanisms are again unclear.
The combination of OSA and COPD may lead to profound hypoxemia. Individuals with COPD can develop pulmonary hypertension via disturbances in gas exchange and parenchymal injury leading to loss of pulmonary vasculature. OSA has been associated with mild to moderate pulmonary hypertension, but the situation may be worse if combined with parenchymal lung disease. The biological response to sustained hypoxemia has been carefully studied as has the topic of intermittent hypoxemia; however, to our knowledge, very little research has occurred regarding the combination of sustained plus intermittent hypoxia as seen in OVS. For example, we do not really know whether individuals with OVS develop coronary disease, right or left heart failure, dysrhythmias or some combination of abnormalities predisposing them to cardiovascular death. Thus, design of interventional studies is challenging as causal pathways are poorly understood despite our considerable preliminary data addressing these issues.
The purpose of this study is to examine vascular mechanisms in individuals with COPD/OSA overlap syndrome (OVS) compared with matched individuals with obstructive sleep apnea (OSA) alone or chronic obstructive pulmonary disease (COPD) alone and to perform a phase II pilot mechanistic clinical trial in OVS to examine the effect size of nocturnal bi-level positive airway pressure (PAP) vs. nocturnal oxygen therapy in cardiovascular outcomes.
Read the detailed description
For Aim 1, we will perform a cross-sectional clinical study that will allow us to test the hypothesis that individuals with OVS have increased markers of vascular risk compared with matched individuals with OSA alone or COPD alone. This aim will also allow us to compare the magnitude of the effect of OSA vs. COPD vs OVS for design of subsequent basic and clinical studies.
For Aim 2, we will perform a randomized 1:1 clinical trial stratified by sex that will allow us to test the hypothesis that bi-level PAP therapy is superior to oxygen in the treatment of individuals with OVS from the standpoint of right ventricular mass (primary outcome) and other cardiovascular risk parameters/outcomes. We will use these interventions as tools to explore their impacts on important biomarkers of interest e.g., miR210 may predict risk of atherosclerosis and changes in levels may give insight into mechanisms of our interventions. There is no sub-study analysis. The aim of the interventional section of this study (aim 2) is to analyze the effect on cardiovascular outcomes of both nocturnal oxygen therapy and bi-level therapy on patients with COPD-OSA overlap syndrome.
Participants will undergo the following activities:
- Eligibility screening (online or via phone; ~10 minutes)
- Subjects who screen positive: In-person eligibility assessment (~1.5 hours) including a history, exam, questionnaires, spirometry, and an overnight home sleep test.
- Participants who are eligible: Will come to the research lab for an overnight visit (~12 hours) which includes the following activities: general exam, questionnaires, blood test, measures of cardiovascular health (e.g., blood pressure), neurocognitive function (e.g., a memory test), a pulmonary function test, and an overnight sleep study to assess the severity of sleep apnea.
- After overnight visit 1, participants will come to day time visit 2 for the cardiac MRI. After this visit, participants who are only COPD or only OSA will have completed the study. Participants with OVS will be offered to continue the study. Participants will come to the research lab for a mask adaptation day visit; if they can tolerate a bilevel mask, they will be randomized to the oxygen versus the bi-level arm. We will ask participants to be on the therapy for 6 months, during which time the research team will make weekly calls to check adherence to the therapies.
- After 6 months on the treatment, OVS participants will come back to an overnight visit which includes the following tests: general exam, questionnaires, blood test, measures of cardiovascular health (e.g., blood pressure), neurocognitive function (e.g., a memory test), and an overnight sleep study. Additionally, they will have a day time visit for the Cardiac MRI.
Researchers will compare the effects of bi-level PAP on cardiovascular health with the effects of oxygen to see if bi-level may be an effective treatment for select patients with OVS.
- Being tested
- bi-level positive pressure non invasive ventilation, Oxygen gas
- Keywords
- OSA, obstructive sleep apnea, COPD, chronic obstructive pulmonary disease, PAP therapy, oxygen, cardiovascular health
- Medical subject headings
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bi-level positive pressure non invasive ventilationDevice
Also called Auto-bilevel, BIPAP, Non invasive ventilation
Participants randomized to the bi-level arm will be provided with an auto bi-level device that automatically delivers the required pressure. The settings in the auto bi-level will be minimum EPAP of 4 cmH2O, maximum IPAP of 24 cmH2O, and a range of pressure support between 6-10 cmH2O. For those participants who have been randomized to the bi-level group but have not successfully acclimated to the device with the automatic bi-level settings, we will conduct an in-lab titration of the bi-level therapy during the optional Overnight visit 2.
Oxygen gasDrug
Also called O2
The dose of nocturnal oxygen in all participants in the oxygen therapy arm will be 2 liters/minute. Patients with daytime hypoxemia, measured as sustained desaturations below 89% during wake time and/or arterial blood PO2 ≤ 55 mmHg, will be excluded from this study (as specified in the exclusion criteria) for ethical reasons since withholding oxygen in hypoxemic patients would be at odds with standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | Experimental | OVS subjects will receive treatment with oxygen during night time for 6 months Receives: Drug: Oxygen gas |
| Bi-level positive pressure non invasive ventilation | Experimental | OVS subjects will receive treatment with bi-level PAP therapy during night time for 6 months Receives: Device: bi-level positive pressure non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular mass
Cardiac magnet resonance imaging (CMRI): All subjects will undergo cardiac MRI measurements the same day they undergo the evaluation of vascular reactivity measurements. Supine cardiac MRI imaging will be performed using a 3T MR scanner (GE 750, GE Healthcare) with a 16-element cardiac coil for radiofrequency signal reception. Non-invasive blood pressure will be monitored during cardiac MRI scanning (Dinemap). Standard and novel MRI sequences will be used for myocardial tissue characterization, assessment of ventricular function, pulmonary hemodynamics, and aortic compliance
Measured: 6 Months
Reactive Hyperemia Index
Based on a device called EndoPAT, which measures non-invasively bloodflow before, during, and after 5-minutes of occlusion to one arm.
Measured: 6 months
5th generation troponin
Troponin will be measured from participant serum samples. Troponin is a marker of myocardial injury.
Measured: 6 months
MiR-210
MicroRNA-210 will be measured from participant serum samples. miR210 may predict risk of atherosclerosis and changes in levels may give insight into mechanisms of our interventions
Measured: 6 months
Secondary outcomes (2)
Verbal Paired-Associates task
Participants will complete a word pairs task, which is a computerized memory assessment designed to prime participants to memorize 26 pairs of words in the evening. To assess sleep-dependent memory consolidation, recall of these word pairs are tested in the morning after the overnight sleep study.
Measured: 6 months
Response Speed
Objective assessment of brain function will be done using 10-minute psychomotor vigilance test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start13 Feb 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6-month, 2-arm randomized, parallel, interventional mechanistic study of COPD/OSA overlap syndrome to compare bi-level PAP vs. O2 therapy Qualified participants will be randomized to receive either O2 therapy or bi-level therapy.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atul Malhotra, University of California, San Diego
- Investigators
- Atul Malhotra, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237505
- Sponsor's protocol ID
- 808025
- Acronym
- CRESCENDO-SLP
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2022
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
- ClinicalTrials.gov ID
- NCT05237505
- Acronym / sponsor ID
- CRESCENDO-SLP / 808025
- Keywords
- OSA, obstructive sleep apnea, COPD, chronic obstructive pulmonary disease, PAP therapy, oxygen, cardiovascular health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 14 Feb 2022 (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.
Major progress has been made in the area of cardiovascular disease, but we believe that further progress will involve mechanistically addressing underlying respiratory causes including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The most common cause of death in COPD is cardiovascular, although mechanisms are unknown. OSA has been associated with major neurocognitive and cardiovascular sequelae, the latter likely a function of autonomic nervous system abnormalities, oxidative stress, inflammation, and other pathways. Recent data suggest that individuals with OVS die preferentially of cardiovascular disease compared to OSA or COPD alone, although mechanisms are again unclear.
The combination of OSA and COPD may lead to profound hypoxemia. Individuals with COPD can develop pulmonary hypertension via disturbances in gas exchange and parenchymal injury leading to loss of pulmonary vasculature. OSA has been associated with mild to moderate pulmonary hypertension, but the situation may be worse if combined with parenchymal lung disease. The biological response to sustained hypoxemia has been carefully studied as has the topic of intermittent hypoxemia; however, to our knowledge, very little research has occurred regarding the combination of sustained plus intermittent hypoxia as seen in OVS. For example, we do not really know whether individuals with OVS develop coronary disease, right or left heart failure, dysrhythmias or some combination of abnormalities predisposing them to cardiovascular death. Thus, design of interventional studies is challenging as causal pathways are poorly understood despite our considerable preliminary data addressing these issues.
The purpose of this study is to examine vascular mechanisms in individuals with COPD/OSA overlap syndrome (OVS) compared with matched individuals with obstructive sleep apnea (OSA) alone or chronic obstructive pulmonary disease (COPD) alone and to perform a phase II pilot mechanistic clinical trial in OVS to examine the effect size of nocturnal bi-level positive airway pressure (PAP) vs. nocturnal oxygen therapy in cardiovascular outcomes.
Detailed description
For Aim 1, we will perform a cross-sectional clinical study that will allow us to test the hypothesis that individuals with OVS have increased markers of vascular risk compared with matched individuals with OSA alone or COPD alone. This aim will also allow us to compare the magnitude of the effect of OSA vs. COPD vs OVS for design of subsequent basic and clinical studies.
For Aim 2, we will perform a randomized 1:1 clinical trial stratified by sex that will allow us to test the hypothesis that bi-level PAP therapy is superior to oxygen in the treatment of individuals with OVS from the standpoint of right ventricular mass (primary outcome) and other cardiovascular risk parameters/outcomes. We will use these interventions as tools to explore their impacts on important biomarkers of interest e.g., miR210 may predict risk of atherosclerosis and changes in levels may give insight into mechanisms of our interventions. There is no sub-study analysis. The aim of the interventional section of this study (aim 2) is to analyze the effect on cardiovascular outcomes of both nocturnal oxygen therapy and bi-level therapy on patients with COPD-OSA overlap syndrome.
Participants will undergo the following activities:
- Eligibility screening (online or via phone; ~10 minutes)
- Subjects who screen positive: In-person eligibility assessment (~1.5 hours) including a history, exam, questionnaires, spirometry, and an overnight home sleep test.
- Participants who are eligible: Will come to the research lab for an overnight visit (~12 hours) which includes the following activities: general exam, questionnaires, blood test, measures of cardiovascular health (e.g., blood pressure), neurocognitive function (e.g., a memory test), a pulmonary function test, and an overnight sleep study to assess the severity of sleep apnea.
- After overnight visit 1, participants will come to day time visit 2 for the cardiac MRI. After this visit, participants who are only COPD or only OSA will have completed the study. Participants with OVS will be offered to continue the study. Participants will come to the research lab for a mask adaptation day visit; if they can tolerate a bilevel mask, they will be randomized to the oxygen versus the bi-level arm. We will ask participants to be on the therapy for 6 months, during which time the research team will make weekly calls to check adherence to the therapies.
- After 6 months on the treatment, OVS participants will come back to an overnight visit which includes the following tests: general exam, questionnaires, blood test, measures of cardiovascular health (e.g., blood pressure), neurocognitive function (e.g., a memory test), and an overnight sleep study. Additionally, they will have a day time visit for the Cardiac MRI.
Researchers will compare the effects of bi-level PAP on cardiovascular health with the effects of oxygen to see if bi-level may be an effective treatment for select patients with OVS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 6-month, 2-arm randomized, parallel, interventional mechanistic study of COPD/OSA overlap syndrome to compare bi-level PAP vs. O2 therapy Qualified participants will be randomized to receive either O2 therapy or bi-level therapy.
| Arm | Type | Receives |
|---|---|---|
| Oxygen | Experimental | Drug: Oxygen gasOVS subjects will receive treatment with oxygen during night time for 6 months |
| Bi-level positive pressure non invasive ventilation | Experimental | Device: bi-level positive pressure non invasive ventilationOVS subjects will receive treatment with bi-level PAP therapy during night time for 6 months |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 40-79.
- For women, only postmenopausal women will be included
- Diagnosed with untreated moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events/hr and ≤80 events/hr) and/or diagnosed with COPD with FEV1/FVC ratio <0.7 and will be on stable medications as assessed by a board-certified pulmonologist.
Key exclusion criteria (16 listed)
- Premenopausal women (i.e. women are pregnant or may become pregnant) or lactation
- Presence of specific devices: cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices, metallic foreign bodies, implantable neurostimulation systems, cochlear implants/ear implant, drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps), metallic fragments such as bullets, shotgun pellets, and metal shrapnel , cerebral artery aneurysm clips, magnetic dental implants, and artificial limb.
- Known allergic reactions to components of the study intervention: (if getting contrast, MRI contrast (gadolinium)).
- Concurrent severe sleep disorders (such as periodic limb movements, restless legs syndrome, narcolepsy, idiopathic hypersomnia, etc).
- Exhibit Cheyne-Stokes respiration or central sleep apnea (> 25 % of events central)
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 |
|---|---|---|
| bi-level positive pressure non invasive ventilationAlso: Auto-bilevel, BIPAP, Non invasive ventilationParticipants randomized to the bi-level arm will be provided with an auto bi-level device that automatically delivers the required pressure. The settings in the auto bi-level will be minimum EPAP of 4 cmH2O, maximum IPAP of 24 cmH2O, and a range of pressure support between 6-10 cmH2O. For those participants who have been randomized to the bi-level group but have not successfully acclimated to the device with the automatic bi-level settings, we will conduct an in-lab titration of the bi-level therapy during the optional Overnight visit 2. | Device | Bi-level positive pressure non invasive ventilation |
| Oxygen gasAlso: O2The dose of nocturnal oxygen in all participants in the oxygen therapy arm will be 2 liters/minute. Patients with daytime hypoxemia, measured as sustained desaturations below 89% during wake time and/or arterial blood PO2 ≤ 55 mmHg, will be excluded from this study (as specified in the exclusion criteria) for ethical reasons since withholding oxygen in hypoxemic patients would be at odds with standard of care. | Drug | Oxygen |
Primary outcome
Right ventricular mass
Time frame: 6 Months
Cardiac magnet resonance imaging (CMRI): All subjects will undergo cardiac MRI measurements the same day they undergo the evaluation of vascular reactivity measurements. Supine cardiac MRI imaging will be performed using a 3T MR scanner (GE 750, GE Healthcare) with a 16-element cardiac coil for radiofrequency signal reception. Non-invasive blood pressure will be monitored during cardiac MRI scanning (Dinemap). Standard and novel MRI sequences will be used for myocardial tissue characterization, assessment of ventricular function, pulmonary hemodynamics, and aortic compliance
Reactive Hyperemia Index
Time frame: 6 months
Based on a device called EndoPAT, which measures non-invasively bloodflow before, during, and after 5-minutes of occlusion to one arm.
5th generation troponin
Time frame: 6 months
Troponin will be measured from participant serum samples. Troponin is a marker of myocardial injury.
MiR-210
Time frame: 6 months
MicroRNA-210 will be measured from participant serum samples. miR210 may predict risk of atherosclerosis and changes in levels may give insight into mechanisms of our interventions
2 secondary outcomes
Verbal Paired-Associates task
Time frame: 6 months
Response Speed
Time frame: 6 months
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Atul Malhotra, MD principal investigator
UCSD
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 bi-level positive pressure non invasive ventilation and Oxygen gas in people with Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease, run by University of California, San Diego 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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?
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 Pamela DeYoung, BA (8582462183, pdeyoung@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular mass (time frame: 6 Months). The study lists 4 primary outcomes in all. 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 Jun 2026.