Patent Foramen OvaleNCT03904277
Does Patent Foramen Ovale Size Matter in Men and Women
An observational study of Patent Foramen Ovale, run by University of Oregon at 1 site in United States.
Trial summary
A patent foramen ovale (PFO) is present in ~30% of the general population. The PFO has historically been considered to be trivial. However, recent work by the investigator's group and others has identified that, compared to individuals without a PFO, those with a PFO have worse pulmonary gas exchange efficiency, have… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patent Foramen Ovale
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 25 Jan 2023
- Phase
- Observational
- 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 40 years
- All sexes
- Adult
Study population: Healthy adults aged 18-40 with and without a PFO.
Who may be able to join
- Men and women aged 18-40
- Known to have/not have a PFO.
Who cannot join
- Previous history of coronary artery disease(ischemic heart disease such as angina, heart attack, myocardial infarction).
- Failure of Modified Allen's Test in both hands.
- Currently taking medications or herbal supplements for any heart or respiratory disease that they cannot stop taking for 48 hrsprior to testing (seasonal allergy medication not included in exclusion medications).
- Lidocaine, nitroglycerine or heparin allergy.
- Women who are pregnant or trying to become pregnant.
- Previous history of any condition that would prevent the subject from performing cycle ergometer exercise (for exercise study only).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiorespiratory and Pulmonary Physiology Lab
Eugene, Oregon, 97403
About this study
A patent foramen ovale (PFO) is present in ~30% of the general population. The PFO has historically been considered to be trivial. However, recent work by the investigator's group and others has identified that, compared to individuals without a PFO, those with a PFO have worse pulmonary gas exchange efficiency, have a higher core body temperature, blunted ventilatory responses to chronic hypoxia and acute carbon dioxide and increased susceptibility to altitude illnesses such as acute mountain sickness, and high altitude pulmonary edema (Lovering, Elliott \& Davis J Appl Physiol 2016). Specific to this application,subjects with a PFO may have worse pulmonary gas exchange efficiency because a PFO is a potential source of right-to-left shunt that will make pulmonary gas exchange efficiency worse. If true, then this may negatively impact exercise capacity and/or exercise tolerance. Further, in those with a PFO compared to those without, preliminary work from the investigator's lab indicates that there may be an effect of PFO size on pulmonary gas exchange efficiency. This is such that those with a large PFO (grade 3 or higher) display significantly worse gas exchange efficiency compared to those with a small (grade 2 or lower) or no PFO,even at low exercise workloads. Additionally, the investigators were curious as to whether there would be a sex effect, but due to logistical constraints, the investigators were unable to recruit an equal number of female and male subjects. Thus, in addition to the potential size effect on the investigators outcome measures, the investigators would like to build on this work by examining the potential effect of biological sex. Although a PFO has been traditionally considered to have a minimal impact of physiology and pathophysiology, emerging evidence suggests this may not be the case. The investigator's lab is focused on understanding how and why a relatively small hole in the heart (PFO) can have a relatively large impact on cardiopulmonary and respiratory physiology, and how these impacts may be based on the size of the PFO.
- Conditions
- Patent Foramen Ovale
- 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.
| Study group | Role | What they receive |
|---|---|---|
| No PFO | Research subjects who present no evidence of PFO - IE no appearance of saline contrast microbubbles within 3 cardiac cycles | |
| Small PFO | Research subjects who present evidence of having a small PFO or ASD - IE appearance of 1-11 saline contrast microbubbles within 3 cardiac cycles | |
| Large PFO | Research subjects who present evidence of having a large PFO - IE appearance of 12+ saline contrast microbubbles within 3 cardiac cycles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
alveolar-arterial difference in oxygen
difference in the partial pressure of oxygen between the alveoli (calculated) and arterial blood (direct measure)
Measured: Baseline
aerobic exercise capacity
ability to utilize oxygen while exercising, AKA Vo2MAX
Measured: Baseline
six-minute walk test
distance covered in 6 minutes of walking
Measured: Baseline
minute flow of intrapulmonary areterio-venous anastamoses (QIPAVA)
minute flow through intrapulmonary arteriovenous anastamoses
Measured: Baseline
core body temperature
subject's core body temperature as measured through an ingestible pill
Measured: Baseline
level of tumor necrosis factor alpha
inflammatory marker
Measured: Baseline
level of C-C motif cytokine 2
inflammatory marker
Measured: Baseline
level of interferon alpha 2
inflammatory marker
Measured: Baseline
level of interferon gamma
inflammatory marker
Measured: Baseline
level of interleukin 1 beta
inflammatory marker
Measured: Baseline
level of interleukin 6
inflammatory marker
Measured: Baseline
level of interleukin 8
inflammatory marker
Measured: Baseline
level of interleukin 10
inflammatory marker
Measured: Baseline
level of interleukin 12p70
inflammatory marker
Measured: Baseline
level of interleukin 17 alpha
inflammatory marker
Measured: Baseline
level of interleukin 18
inflammatory marker
Measured: Baseline
level of interleukin 23
inflammatory marker
Measured: Baseline
level of interleukin 33
inflammatory marker
Measured: Baseline
level of myoglobin
inflammatory marker
Measured: Baseline
level of myeloid-related protein 8/14
inflammatory marker
Measured: Baseline
level of neutrophil gelatinase-associated lipocalin
inflammatory marker
Measured: Baseline and 3 months post percutaneous closure
level of c-reactive protein
inflammatory marker
Measured: Baseline
matrix metallopeptidase 2
inflammatory marker
Measured: Baseline and 3 months post percutaneous closure
level of osteopontin
inflammatory marker
Measured: Baseline
level of myloperoxidase
inflammatory marker
Measured: Baseline
level of Serum amyloid A
inflammatory marker
Measured: Baseline
level of insulin like growth factor binding protein 4
inflammatory marker
Measured: Baseline
level of intracellular adhesion molecule 1
inflammatory marker
Measured: Baseline
level of vascular cell adhesion protein 1
inflammatory marker
Measured: Baseline
level of metallopeptidase 9
inflammatory marker
Measured: Baseline
level of Cystatin C
inflammatory marker
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Oct 2018
- Primary completion31 Dec 2022
- Study completion25 Jan 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904277
- Sponsor's protocol ID
- 04302018.049
- Status last verified
- Sep 2022
- First submitted
- 1 Apr 2019
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Patent Foramen Ovale Size Matter in Men and Women
- ClinicalTrials.gov ID
- NCT03904277
- Acronym / sponsor ID
- 04302018.049
- Conditions
- Patent Foramen Ovale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 5 Apr 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.
A patent foramen ovale (PFO) is present in ~30% of the general population. The PFO has historically been considered to be trivial. However, recent work by the investigator's group and others has identified that, compared to individuals without a PFO, those with a PFO have worse pulmonary gas exchange efficiency, have a higher core body temperature, blunted ventilatory responses to chronic hypoxia and acute carbon dioxide and increased susceptibility to altitude illnesses such as acute mountain sickness, and high altitude pulmonary edema (Lovering, Elliott \& Davis J Appl Physiol 2016). Specific to this application,subjects with a PFO may have worse pulmonary gas exchange efficiency because a PFO is a potential source of right-to-left shunt that will make pulmonary gas exchange efficiency worse. If true, then this may negatively impact exercise capacity and/or exercise tolerance. Further, in those with a PFO compared to those without, preliminary work from the investigator's lab indicates that there may be an effect of PFO size on pulmonary gas exchange efficiency. This is such that those with a large PFO (grade 3 or higher) display significantly worse gas exchange efficiency compared to those with a small (grade 2 or lower) or no PFO,even at low exercise workloads. Additionally, the investigators were curious as to whether there would be a sex effect, but due to logistical constraints, the investigators were unable to recruit an equal number of female and male subjects. Thus, in addition to the potential size effect on the investigators outcome measures, the investigators would like to build on this work by examining the potential effect of biological sex. Although a PFO has been traditionally considered to have a minimal impact of physiology and pathophysiology, emerging evidence suggests this may not be the case. The investigator's lab is focused on understanding how and why a relatively small hole in the heart (PFO) can have a relatively large impact on cardiopulmonary and respiratory physiology, and how these impacts may be based on the size of the PFO.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No PFO | – | –Research subjects who present no evidence of PFO - IE no appearance of saline contrast microbubbles within 3 cardiac cycles |
| Small PFO | – | –Research subjects who present evidence of having a small PFO or ASD - IE appearance of 1-11 saline contrast microbubbles within 3 cardiac cycles |
| Large PFO | – | –Research subjects who present evidence of having a large PFO - IE appearance of 12+ saline contrast microbubbles within 3 cardiac cycles. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy adults aged 18-40 with and without a PFO.
Key inclusion criteria (2 listed)
- Men and women aged 18-40
- Known to have/not have a PFO.
Key exclusion criteria (6 listed)
- Previous history of coronary artery disease(ischemic heart disease such as angina, heart attack, myocardial infarction).
- Failure of Modified Allen's Test in both hands.
- Currently taking medications or herbal supplements for any heart or respiratory disease that they cannot stop taking for 48 hrsprior to testing (seasonal allergy medication not included in exclusion medications).
- Lidocaine, nitroglycerine or heparin allergy.
- Women who are pregnant or trying to become pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
alveolar-arterial difference in oxygen
Time frame: Baseline
difference in the partial pressure of oxygen between the alveoli (calculated) and arterial blood (direct measure)
aerobic exercise capacity
Time frame: Baseline
ability to utilize oxygen while exercising, AKA Vo2MAX
six-minute walk test
Time frame: Baseline
distance covered in 6 minutes of walking
minute flow of intrapulmonary areterio-venous anastamoses (QIPAVA)
Time frame: Baseline
minute flow through intrapulmonary arteriovenous anastamoses
core body temperature
Time frame: Baseline
subject's core body temperature as measured through an ingestible pill
level of tumor necrosis factor alpha
Time frame: Baseline
inflammatory marker
level of C-C motif cytokine 2
Time frame: Baseline
inflammatory marker
level of interferon alpha 2
Time frame: Baseline
inflammatory marker
level of interferon gamma
Time frame: Baseline
inflammatory marker
level of interleukin 1 beta
Time frame: Baseline
inflammatory marker
level of interleukin 6
Time frame: Baseline
inflammatory marker
level of interleukin 8
Time frame: Baseline
inflammatory marker
level of interleukin 10
Time frame: Baseline
inflammatory marker
level of interleukin 12p70
Time frame: Baseline
inflammatory marker
level of interleukin 17 alpha
Time frame: Baseline
inflammatory marker
level of interleukin 18
Time frame: Baseline
inflammatory marker
level of interleukin 23
Time frame: Baseline
inflammatory marker
level of interleukin 33
Time frame: Baseline
inflammatory marker
level of myoglobin
Time frame: Baseline
inflammatory marker
level of myeloid-related protein 8/14
Time frame: Baseline
inflammatory marker
level of neutrophil gelatinase-associated lipocalin
Time frame: Baseline and 3 months post percutaneous closure
inflammatory marker
level of c-reactive protein
Time frame: Baseline
inflammatory marker
matrix metallopeptidase 2
Time frame: Baseline and 3 months post percutaneous closure
inflammatory marker
level of osteopontin
Time frame: Baseline
inflammatory marker
level of myloperoxidase
Time frame: Baseline
inflammatory marker
level of Serum amyloid A
Time frame: Baseline
inflammatory marker
level of insulin like growth factor binding protein 4
Time frame: Baseline
inflammatory marker
level of intracellular adhesion molecule 1
Time frame: Baseline
inflammatory marker
level of vascular cell adhesion protein 1
Time frame: Baseline
inflammatory marker
level of metallopeptidase 9
Time frame: Baseline
inflammatory marker
level of Cystatin C
Time frame: Baseline
inflammatory marker
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 1 Feb 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale, 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 2 inclusion and 6 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 1 Feb 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
alveolar-arterial difference in oxygen (time frame: Baseline). The study lists 31 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 1 Feb 2023.