Does Patent Foramen Ovale Size Matter in Men and Women

Patent Foramen Ovale Clinical Trial

Official title:

Does Patent Foramen Ovale Size Matter in Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904277
• Other study ID #: 04302018.049
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: January 25, 2023

Study information

• Verified date: September 2022
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 25, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale

Locations

Country	Name	City	State
United States	Cardiorespiratory and Pulmonary Physiology Lab	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

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