Patent Foramen OvaleEarly Phase 1NCT03945643
Is Blood Flow Through IPAVA and PFO Related to Breath-hold and SCUBA Diving-induced Pulmonary Hypertension?
A Early Phase 1 study testing Sildenafil in people with Patent Foramen Ovale and Intrapulmonary Arteriovenous Anastamosis, run by University of Oregon at 1 site in United States.
Trial summary
In summary, the investigators propose to study elite Croatian breath-hold and SCUBA divers. The investigators will quantify breath-hold hypoxia- and SCUBA diving-induced pulmonary hypertension and right heart function to investigate the relationships between PFO and IPAVA blood flow. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patent Foramen Ovale, Intrapulmonary Arteriovenous Anastamosis
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Jul 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reside in geographic location near Split, Croatia
- Elite breath hold divers
- Experienced SCUBA divers
Who cannot join
- Previous history of coronary artery disease
- Currently taking medication or herbal supplement for any heart or respiratory disease that cannot be ceased for 48 hours prior to testing
- Women who are pregnant or trying to become pregnant
- Previous history of any condition that would prevent the subject from performing a breath hold
- Taking sildenafil or products similar to sildenafil
- Taking Nitrates or other nitric oxide donors
- Control breath hold divers can't have previous breath hold diving experience
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiorespiratory and Pulmonary Physiology Lab
Eugene, Oregon, 97403
About this study
In summary, the investigators propose to study elite Croatian breath-hold and SCUBA divers. The investigators will quantify breath-hold hypoxia- and SCUBA diving-induced pulmonary hypertension and right heart function to investigate the relationships between PFO and IPAVA blood flow. The investigators will use a placebo-controlled intervention (sildenafil) to reduce pulmonary arterial pressure in these subjects to examine the impact of the change in pressure (or absence of change) on the relationships determined above.
Read the detailed description
Pulmonary arterial hypertension (increased lung blood pressure) is a multifactorial disease without a cure. Investigating reversible forms of pulmonary hypertension induced under extreme conditions such as a prolonged breath-hold and/or SCUBA diving may help to better understand why some individuals develop this devastating disease, and others do not.
Pulmonary arterial pressure is typically very low in healthy humans. Low oxygen levels (hypoxia) cause a constriction of the lung blood vessels resulting in smaller diameters, but lung blood flow stays constant or increases. Having constant flow with smaller vessel diameters causes pulmonary arterial pressure to increase but it will return to normal once normal oxygen levels are restored. Moreover, there is an association with patent foramen ovale (PFO, small hole between the atria in the heart) and excessive pulmonary arterial pressures in low oxygen conditions. However, the reasons for the exacerbated increase in pulmonary arterial pressure in these subjects with a PFO (PFO+) is unknown, but may be due to an exaggerated constriction response to low oxygen.
During a breath-hold, the oxygen in the lung decreases and in elite breath-hold divers, it decreases to very low levels. Compared to subjects without a PFO (PFO-), the oxygen may drop even lower in those PFO+ subjects because deoxygenated blood travels through the small hole to mix with oxygenated blood, exacerbating the level to which blood oxygen decreases. Thus, using a breath-hold model of lung hypoxia is one approach to examining a hypoxia-induced increase in pulmonary arterial pressure - a method critically dependent upon the elite breath-hold diver's ability to hold their breath for significant durations.
Intrapulmonary arteriovenous anastomoses (IPAVA) are vessels within the lung that bypass capillaries. The investigator's group has investigated the possible roles these unique vessels may have in physiological and pathophysiological conditions. The investigators have found that IPAVA blood flow occurs when healthy subjects breathe low oxygen gas. The investigators have also found that IPAVA blood flow is inversely related to pulmonary arterial pressure. Specifically, individuals with high pulmonary arterial pressures have low IPAVA blood flow and vice versa.
The right ventricle of the heart pumps blood through the pulmonary artery to the lungs. Under resting conditions the right heart performs a minimal amount of work because the pressure in the lung blood vessels is low. When pulmonary arterial pressure increases, the work of the right side of the heart has to increase substantially to keep blood pumping through the lung. Thus, high pulmonary arterial pressures will increase the work of the right heart and may lead to right heart dysfunction thereby limiting the amount of blood the heart can pump. If the pressure is high enough to limit the amount of blood flowing through the lung then this can be detected by a reduction in pulmonary blood flow and/or changes in the function of the heart during contraction (systole) and relaxation (diastole). Accordingly, an intervention that reduces pulmonary arterial pressures during a breath-hold may have a beneficial effect on right heart function.
Taken together, during an elite breath-hold dive, where the level of oxygen decreases, the investigators expect that pulmonary arterial pressures will increase as lung oxygen levels decrease, and the reduction in oxygen may be even lower in PFO+ subjects. Furthermore, as blood oxygen levels decrease, IPAVA blood flow will increase in some PFO- subjects thereby keeping pulmonary arterial pressures low in those individuals. Conversely, PFO+ subjects and those PFO- subjects with low levels of IPAVA blood flow would be expected to have the greatest pulmonary pressures. Whether or not this is true is unknown. Therefore, Objective #1 will quantify pulmonary arterial pressure and right heart function and investigate their relationships with PFO and IPAVA blood flow in elite breath-hold divers while breathing concentrations of oxygen and carbon dioxide that mimic breath-hold-induced hypoxia [NOTE: it is not possible to image the heart during a breath hold because the fully inflated lung obstructs the ultrasound view of the heart]. Objective #2 will use sildenafil, a drug that increases nitric oxide bioavailability to dilate lung blood vessels, to decrease pulmonary arterial pressure while breathing concentrations of oxygen and carbon dioxide that mimic breath-hold-induced hypoxia. Investigators will quantify the effect of sildenafil on pulmonary arterial pressure and right heart function and will determine if it alters the relationship with IPAVA and PFO blood flow. As mentioned above, because those PFO+ subjects may have an exaggerated pulmonary vasoconstrictor response to hypoxia, sildenafil may be either less effective or ineffective in reducing the pulmonary arterial pressure in these subjects. Objective #3 will compare the elite breath hold diver study data to data obtained in age, sex and PFO matched subjects who do not have extensive experience with breath hold diving. To do this control subjects will undergo the same procedures in Objectives #1 \& 2 above. These studies will also allow investigators to determine if there are differences in pulmonary vascular responses to hypoxia between those with and without breath hold diving experience.
In addition to the heart and lung alterations that occur in breath hold divers outlined above, it is also known that pulmonary arterial pressure increases after SCUBA diving, but returns to normal within a few hours. The mechanisms responsible for the increase in pulmonary arterial pressure are unknown, but are independent of hypoxia. Thus, investigating the relationship between IPAVA, PFO and SCUBA diving-induced increases in pulmonary arterial pressures offers an additional avenue for understanding pulmonary arterial hypertension susceptibility. Although it is unknown why pulmonary arterial pressure increases with SCUBA diving, it is known that pulmonary hypertension may contribute to right heart dysfunction and pulmonary edema (lung water accumulation) that can occur in subjects who are swimming and/or SCUBA diving. Prevention of increased pulmonary arterial pressures during and/or after a dive may help to prevent excessive right heart dysfunction and pulmonary edema. Thus, Objective #4 will quantify pulmonary arterial pressure and right heart function and investigate their relationships with PFO and IPAVA blood flow, pre- and post-SCUBA diving. Objective #5 will quantify the effect of sildenafil (post dive) on pulmonary arterial pressure and right heart function and will determine if it alters the relationship with IPAVA and PFO blood flow, pre- and post-SCUBA diving.
In summary, the investigators propose to study elite Croatian breath-hold and SCUBA divers. Investigators will quantify breath-hold hypoxia- and SCUBA diving-induced pulmonary hypertension and right heart function to investigate the relationships between PFO and IPAVA blood flow. Investigators will use a placebo-controlled intervention (sildenafil) to reduce pulmonary arterial pressure in these subjects to examine the impact of the change in pressure (or absence of change) on the relationships determined above.
- Being tested
- Sildenafil, Placebo
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
50mg administration of sildenafil, one time, one hour prior to measurements.
PlaceboOther
50mg administration in gel-encapsulated microcrystalline cellulose one time, one hour prior to measurements.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil administration | Active comparator | Administration of 50mg sildenafil one time, one hour prior to measurements Receives: Drug: Sildenafil |
| Placebo administration | Placebo comparator | Administration of 50mg placebo one time, one hour prior to measurements Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Pressure
Pulmonary arterial pressure measured by ultrasound techniques
Measured: 1 hour post intervention
Concentration of Myoglobin
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration of MRP8/14
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration of NGAL
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration Of CRP
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration Of MMP-2
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration of OPN
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration Of SAA
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration of IGFBP-4
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration of ICAM-1
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration of VCAM-1
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration of MMP-9
Inflammatory cytokine
Measured: 1 hour post intervention
Concentration of Cystatin C
Inflammatory cytokine
Measured: 1 hour post intervention
Change in Q-IPAVA
Minute bloodflow through intrapulmonary arteriovenous anastamoses
Measured: 1 hour post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Jul 2019
- Primary completion31 Jan 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen OvaleStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Breath hold divers will be administered sildenafil and placebo. Age-matched controls will be administered sildenafil and placebo.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Lovering, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945643
- Sponsor's protocol ID
- 07302018.031
- Status last verified
- Aug 2023
- First submitted
- 8 May 2019
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to not share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Blood Flow Through IPAVA and PFO Related to Breath-hold and SCUBA Diving-induced Pulmonary Hypertension?
- ClinicalTrials.gov ID
- NCT03945643
- Acronym / sponsor ID
- 07302018.031
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 10 May 2019 (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.
In summary, the investigators propose to study elite Croatian breath-hold and SCUBA divers. The investigators will quantify breath-hold hypoxia- and SCUBA diving-induced pulmonary hypertension and right heart function to investigate the relationships between PFO and IPAVA blood flow. The investigators will use a placebo-controlled intervention (sildenafil) to reduce pulmonary arterial pressure in these subjects to examine the impact of the change in pressure (or absence of change) on the relationships determined above.
Detailed description
Pulmonary arterial hypertension (increased lung blood pressure) is a multifactorial disease without a cure. Investigating reversible forms of pulmonary hypertension induced under extreme conditions such as a prolonged breath-hold and/or SCUBA diving may help to better understand why some individuals develop this devastating disease, and others do not.
Pulmonary arterial pressure is typically very low in healthy humans. Low oxygen levels (hypoxia) cause a constriction of the lung blood vessels resulting in smaller diameters, but lung blood flow stays constant or increases. Having constant flow with smaller vessel diameters causes pulmonary arterial pressure to increase but it will return to normal once normal oxygen levels are restored. Moreover, there is an association with patent foramen ovale (PFO, small hole between the atria in the heart) and excessive pulmonary arterial pressures in low oxygen conditions. However, the reasons for the exacerbated increase in pulmonary arterial pressure in these subjects with a PFO (PFO+) is unknown, but may be due to an exaggerated constriction response to low oxygen.
During a breath-hold, the oxygen in the lung decreases and in elite breath-hold divers, it decreases to very low levels. Compared to subjects without a PFO (PFO-), the oxygen may drop even lower in those PFO+ subjects because deoxygenated blood travels through the small hole to mix with oxygenated blood, exacerbating the level to which blood oxygen decreases. Thus, using a breath-hold model of lung hypoxia is one approach to examining a hypoxia-induced increase in pulmonary arterial pressure - a method critically dependent upon the elite breath-hold diver's ability to hold their breath for significant durations.
Intrapulmonary arteriovenous anastomoses (IPAVA) are vessels within the lung that bypass capillaries. The investigator's group has investigated the possible roles these unique vessels may have in physiological and pathophysiological conditions. The investigators have found that IPAVA blood flow occurs when healthy subjects breathe low oxygen gas. The investigators have also found that IPAVA blood flow is inversely related to pulmonary arterial pressure. Specifically, individuals with high pulmonary arterial pressures have low IPAVA blood flow and vice versa.
The right ventricle of the heart pumps blood through the pulmonary artery to the lungs. Under resting conditions the right heart performs a minimal amount of work because the pressure in the lung blood vessels is low. When pulmonary arterial pressure increases, the work of the right side of the heart has to increase substantially to keep blood pumping through the lung. Thus, high pulmonary arterial pressures will increase the work of the right heart and may lead to right heart dysfunction thereby limiting the amount of blood the heart can pump. If the pressure is high enough to limit the amount of blood flowing through the lung then this can be detected by a reduction in pulmonary blood flow and/or changes in the function of the heart during contraction (systole) and relaxation (diastole). Accordingly, an intervention that reduces pulmonary arterial pressures during a breath-hold may have a beneficial effect on right heart function.
Taken together, during an elite breath-hold dive, where the level of oxygen decreases, the investigators expect that pulmonary arterial pressures will increase as lung oxygen levels decrease, and the reduction in oxygen may be even lower in PFO+ subjects. Furthermore, as blood oxygen levels decrease, IPAVA blood flow will increase in some PFO- subjects thereby keeping pulmonary arterial pressures low in those individuals. Conversely, PFO+ subjects and those PFO- subjects with low levels of IPAVA blood flow would be expected to have the greatest pulmonary pressures. Whether or not this is true is unknown. Therefore, Objective #1 will quantify pulmonary arterial pressure and right heart function and investigate their relationships with PFO and IPAVA blood flow in elite breath-hold divers while breathing concentrations of oxygen and carbon dioxide that mimic breath-hold-induced hypoxia [NOTE: it is not possible to image the heart during a breath hold because the fully inflated lung obstructs the ultrasound view of the heart]. Objective #2 will use sildenafil, a drug that increases nitric oxide bioavailability to dilate lung blood vessels, to decrease pulmonary arterial pressure while breathing concentrations of oxygen and carbon dioxide that mimic breath-hold-induced hypoxia. Investigators will quantify the effect of sildenafil on pulmonary arterial pressure and right heart function and will determine if it alters the relationship with IPAVA and PFO blood flow. As mentioned above, because those PFO+ subjects may have an exaggerated pulmonary vasoconstrictor response to hypoxia, sildenafil may be either less effective or ineffective in reducing the pulmonary arterial pressure in these subjects. Objective #3 will compare the elite breath hold diver study data to data obtained in age, sex and PFO matched subjects who do not have extensive experience with breath hold diving. To do this control subjects will undergo the same procedures in Objectives #1 \& 2 above. These studies will also allow investigators to determine if there are differences in pulmonary vascular responses to hypoxia between those with and without breath hold diving experience.
In addition to the heart and lung alterations that occur in breath hold divers outlined above, it is also known that pulmonary arterial pressure increases after SCUBA diving, but returns to normal within a few hours. The mechanisms responsible for the increase in pulmonary arterial pressure are unknown, but are independent of hypoxia. Thus, investigating the relationship between IPAVA, PFO and SCUBA diving-induced increases in pulmonary arterial pressures offers an additional avenue for understanding pulmonary arterial hypertension susceptibility. Although it is unknown why pulmonary arterial pressure increases with SCUBA diving, it is known that pulmonary hypertension may contribute to right heart dysfunction and pulmonary edema (lung water accumulation) that can occur in subjects who are swimming and/or SCUBA diving. Prevention of increased pulmonary arterial pressures during and/or after a dive may help to prevent excessive right heart dysfunction and pulmonary edema. Thus, Objective #4 will quantify pulmonary arterial pressure and right heart function and investigate their relationships with PFO and IPAVA blood flow, pre- and post-SCUBA diving. Objective #5 will quantify the effect of sildenafil (post dive) on pulmonary arterial pressure and right heart function and will determine if it alters the relationship with IPAVA and PFO blood flow, pre- and post-SCUBA diving.
In summary, the investigators propose to study elite Croatian breath-hold and SCUBA divers. Investigators will quantify breath-hold hypoxia- and SCUBA diving-induced pulmonary hypertension and right heart function to investigate the relationships between PFO and IPAVA blood flow. Investigators will use a placebo-controlled intervention (sildenafil) to reduce pulmonary arterial pressure in these subjects to examine the impact of the change in pressure (or absence of change) on the relationships determined above.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Breath hold divers will be administered sildenafil and placebo. Age-matched controls will be administered sildenafil and placebo.
| Arm | Type | Receives |
|---|---|---|
| Sildenafil administration | Active comparator | Drug: SildenafilAdministration of 50mg sildenafil one time, one hour prior to measurements |
| Placebo administration | Placebo comparator | Other: PlaceboAdministration of 50mg placebo one time, one hour prior to measurements |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Reside in geographic location near Split, Croatia
- Elite breath hold divers
- Experienced SCUBA divers
Key exclusion criteria (7 listed)
- Previous history of coronary artery disease
- Currently taking medication or herbal supplement for any heart or respiratory disease that cannot be ceased for 48 hours prior to testing
- Women who are pregnant or trying to become pregnant
- Previous history of any condition that would prevent the subject from performing a breath hold
- Taking sildenafil or products similar to sildenafil
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 |
|---|---|---|
| Sildenafil50mg administration of sildenafil, one time, one hour prior to measurements. | Drug | Sildenafil administration |
| Placebo50mg administration in gel-encapsulated microcrystalline cellulose one time, one hour prior to measurements. | Other | Placebo administration |
Primary outcome
Pulmonary Pressure
Time frame: 1 hour post intervention
Pulmonary arterial pressure measured by ultrasound techniques
Concentration of Myoglobin
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration of MRP8/14
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration of NGAL
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration Of CRP
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration Of MMP-2
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration of OPN
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration Of SAA
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration of IGFBP-4
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration of ICAM-1
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration of VCAM-1
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration of MMP-9
Time frame: 1 hour post intervention
Inflammatory cytokine
Concentration of Cystatin C
Time frame: 1 hour post intervention
Inflammatory cytokine
Change in Q-IPAVA
Time frame: 1 hour post intervention
Minute bloodflow through intrapulmonary arteriovenous anastamoses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No. Plan to not share IPD.
Related trials for Patent Foramen Ovale
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
Active, not recruiting
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Stroke, Patent Foramen Ovale
RecruitingPhase 3
Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy
Migraine Disease, Patent Foramen Ovale
Recruiting
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
Patent Foramen Ovale, Stroke
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.
Andrew Lovering, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sildenafil in people with Patent Foramen Ovale and Intrapulmonary Arteriovenous Anastamosis, run by University of Oregon 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 7 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 14 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pulmonary Pressure (time frame: 1 hour post intervention). The study lists 14 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 14 Aug 2023.