Does Patent Foramen Ovale Size Matter in Men and Women

Completed

• Conditions: Patent Foramen Ovale

• Registration Number: NCT03904277
• Lead Sponsor: University of Oregon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-05
• Status Verified: 2022-09
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-25
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
six-minute walk test	Baseline	distance covered in 6 minutes of walking
level of interleukin 23	Baseline	inflammatory marker
level of myoglobin	Baseline	inflammatory marker
level of Serum amyloid A	Baseline	inflammatory marker
level of intracellular adhesion molecule 1	Baseline	inflammatory marker
level of metallopeptidase 9	Baseline	inflammatory marker
alveolar-arterial difference in oxygen	Baseline	difference in the partial pressure of oxygen between the alveoli (calculated) and arterial blood (direct measure)
level of tumor necrosis factor alpha	Baseline	inflammatory marker
level of interleukin 1 beta	Baseline	inflammatory marker
matrix metallopeptidase 2	Baseline and 3 months post percutaneous closure	inflammatory marker
level of osteopontin	Baseline	inflammatory marker
level of C-C motif cytokine 2	Baseline	inflammatory marker
level of interferon alpha 2	Baseline	inflammatory marker
level of interleukin 6	Baseline	inflammatory marker
level of interleukin 33	Baseline	inflammatory marker
level of myloperoxidase	Baseline	inflammatory marker
level of Cystatin C	Baseline	inflammatory marker
core body temperature	Baseline	subject's core body temperature as measured through an ingestible pill
minute flow of intrapulmonary areterio-venous anastamoses (QIPAVA)	Baseline	minute flow through intrapulmonary arteriovenous anastamoses
level of interleukin 10	Baseline	inflammatory marker
level of myeloid-related protein 8/14	Baseline	inflammatory marker
level of neutrophil gelatinase-associated lipocalin	Baseline and 3 months post percutaneous closure	inflammatory marker
level of vascular cell adhesion protein 1	Baseline	inflammatory marker
aerobic exercise capacity	Baseline	ability to utilize oxygen while exercising, AKA Vo2MAX
level of interferon gamma	Baseline	inflammatory marker
level of interleukin 8	Baseline	inflammatory marker
level of interleukin 12p70	Baseline	inflammatory marker
level of interleukin 17 alpha	Baseline	inflammatory marker
level of interleukin 18	Baseline	inflammatory marker
level of c-reactive protein	Baseline	inflammatory marker
level of insulin like growth factor binding protein 4	Baseline	inflammatory marker

Trial Locations

Locations (1)

Cardiorespiratory and Pulmonary Physiology Lab; 🇺🇸 Eugene, Oregon, United States