Clinical Trials Directory

Trials / Completed

CompletedNCT03904277

Does Patent Foramen Ovale Size Matter in Men and Women

Status
Completed
Phase
Study type
Observational
Enrollment
28 (actual)
Sponsor
University of Oregon · Academic / Other
Sex
All
Age
18 Years – 40 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2018-10-01
Primary completion
2022-12-31
Completion
2023-01-25
First posted
2019-04-05
Last updated
2023-02-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03904277. Inclusion in this directory is not an endorsement.

Does Patent Foramen Ovale Size Matter in Men and Women (NCT03904277) · Clinical Trials Directory