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Completed

NCT Number: NCT03904277

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 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.

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Key information

Conditions

Patent Foramen Ovale Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiorespiratory and Pulmonary Physiology Lab

Eugene, Oregon, 97403, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. alveolar-arterial difference in oxygen

    Time frame: Baseline

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

  2. aerobic exercise capacity

    Time frame: Baseline

    ability to utilize oxygen while exercising, AKA Vo2MAX

  3. six-minute walk test

    Time frame: Baseline

    distance covered in 6 minutes of walking

  4. minute flow of intrapulmonary areterio-venous anastamoses (QIPAVA)

    Time frame: Baseline

    minute flow through intrapulmonary arteriovenous anastamoses

  5. core body temperature

    Time frame: Baseline

    subject's core body temperature as measured through an ingestible pill

  6. level of tumor necrosis factor alpha

    Time frame: Baseline

    inflammatory marker

  7. level of C-C motif cytokine 2

    Time frame: Baseline

    inflammatory marker

  8. level of interferon alpha 2

    Time frame: Baseline

    inflammatory marker

  9. level of interferon gamma

    Time frame: Baseline

    inflammatory marker

  10. level of interleukin 1 beta

    Time frame: Baseline

    inflammatory marker

  11. level of interleukin 6

    Time frame: Baseline

    inflammatory marker

  12. level of interleukin 8

    Time frame: Baseline

    inflammatory marker

  13. level of interleukin 10

    Time frame: Baseline

    inflammatory marker

  14. level of interleukin 12p70

    Time frame: Baseline

    inflammatory marker

  15. level of interleukin 17 alpha

    Time frame: Baseline

    inflammatory marker

  16. level of interleukin 18

    Time frame: Baseline

    inflammatory marker

  17. level of interleukin 23

    Time frame: Baseline

    inflammatory marker

  18. level of interleukin 33

    Time frame: Baseline

    inflammatory marker

  19. level of myoglobin

    Time frame: Baseline

    inflammatory marker

  20. level of myeloid-related protein 8/14

    Time frame: Baseline

    inflammatory marker

  21. level of neutrophil gelatinase-associated lipocalin

    Time frame: Baseline and 3 months post percutaneous closure

    inflammatory marker

  22. level of c-reactive protein

    Time frame: Baseline

    inflammatory marker

  23. matrix metallopeptidase 2

    Time frame: Baseline and 3 months post percutaneous closure

    inflammatory marker

  24. level of osteopontin

    Time frame: Baseline

    inflammatory marker

  25. level of myloperoxidase

    Time frame: Baseline

    inflammatory marker

  26. level of Serum amyloid A

    Time frame: Baseline

    inflammatory marker

  27. level of insulin like growth factor binding protein 4

    Time frame: Baseline

    inflammatory marker

  28. level of intracellular adhesion molecule 1

    Time frame: Baseline

    inflammatory marker

  29. level of vascular cell adhesion protein 1

    Time frame: Baseline

    inflammatory marker

  30. level of metallopeptidase 9

    Time frame: Baseline

    inflammatory marker

  31. level of Cystatin C

    Time frame: Baseline

    inflammatory marker

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Apr 5, 2019
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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