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NCT03904277 · ClinicalTrials.gov registry record

Does Patent Foramen Ovale Size Matter in Men and Women

A clinical trial of Patent Foramen Ovale, sponsored by University of Oregon.

Completed
Registry status
28
Enrollment target
1
Study location

NCT03904277: Completed study of Patent Foramen Ovale, sponsored by University of Oregon.

NCT03904277 is a study of Patent Foramen Ovale that has completed, run by University of Oregon. The registered enrollment target is 28 participants, below the 417-participant average among 7 other Patent Foramen Ovale trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03904277, a study of Patent Foramen Ovale, has completed, sponsored by University of Oregon.

COMPLETED
Registry status
28 participants
Enrollment target
1
Study location

Study 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 cardiopu

Primary Outcome

difference in the partial pressure of oxygen between the alveoli (calculated) and arterial blood (direct measure)

Conditions Studied

Study Locations (1)

Oregon

  • Cardiorespiratory and Pulmonary Physiology Lab - Eugene

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2018-10-01
Est. Completion 2023-01-25
University of Oregon

63 total trials

What the finished NCT03904277 record still lists

NCT03904277 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 417-participant average among 7 other Patent Foramen Ovale trials with a reported enrollment target (93% lower).

The record links to 1 condition, with Patent Foramen Ovale appearing as the primary indexed condition, and to 0 interventions.

NCT03904277 reports a single indexed study location in Oregon.

Frequently Asked Questions

What is clinical trial NCT03904277 about?

NCT03904277 is a clinical study titled "Does Patent Foramen Ovale Size Matter in Men and Women". 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 exchan...

What is the current status of trial NCT03904277?

This trial is currently completed. The enrollment target is 28 participants. The study started on 2018-10-01. Estimated completion is 2023-01-25.

What conditions does trial NCT03904277 study?

This clinical trial studies the following conditions: Patent Foramen Ovale.

Who is sponsoring clinical trial NCT03904277?

This trial is sponsored by University of Oregon, which has 63 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03904277 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03904277, the US trial registry maintained by the National Library of Medicine. NCT03904277 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.