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Does Patent Foramen Ovale Size Matter in Men and Women

Does Patent Foramen Ovale Size Matter in Men and Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03904277
Enrollment
28
Registered
2019-04-05
Start date
2018-10-01
Completion date
2023-01-25
Last updated
2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Foramen Ovale

Brief 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 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.

Interventions

None listed

Sponsors

University of Oregon
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years

Inclusion criteria

* Men and women aged 18-40 * Known to have/not have a PFO.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
level of insulin like growth factor binding protein 4Baselineinflammatory marker
level of intracellular adhesion molecule 1Baselineinflammatory marker
level of vascular cell adhesion protein 1Baselineinflammatory marker
level of metallopeptidase 9Baselineinflammatory marker
level of Cystatin CBaselineinflammatory marker
level of neutrophil gelatinase-associated lipocalinBaseline and 3 months post percutaneous closureinflammatory marker
level of c-reactive proteinBaselineinflammatory marker
matrix metallopeptidase 2Baseline and 3 months post percutaneous closureinflammatory marker
level of osteopontinBaselineinflammatory marker
level of myloperoxidaseBaselineinflammatory marker
level of Serum amyloid ABaselineinflammatory marker
alveolar-arterial difference in oxygenBaselinedifference in the partial pressure of oxygen between the alveoli (calculated) and arterial blood (direct measure)
aerobic exercise capacityBaselineability to utilize oxygen while exercising, AKA Vo2MAX
six-minute walk testBaselinedistance covered in 6 minutes of walking
minute flow of intrapulmonary areterio-venous anastamoses (QIPAVA)Baselineminute flow through intrapulmonary arteriovenous anastamoses
core body temperatureBaselinesubject's core body temperature as measured through an ingestible pill
level of tumor necrosis factor alphaBaselineinflammatory marker
level of C-C motif cytokine 2Baselineinflammatory marker
level of interferon alpha 2Baselineinflammatory marker
level of interferon gammaBaselineinflammatory marker
level of interleukin 1 betaBaselineinflammatory marker
level of interleukin 6Baselineinflammatory marker
level of interleukin 8Baselineinflammatory marker
level of interleukin 10Baselineinflammatory marker
level of interleukin 12p70Baselineinflammatory marker
level of interleukin 17 alphaBaselineinflammatory marker
level of interleukin 18Baselineinflammatory marker
level of interleukin 23Baselineinflammatory marker
level of interleukin 33Baselineinflammatory marker
level of myoglobinBaselineinflammatory marker
level of myeloid-related protein 8/14Baselineinflammatory marker

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026