Clinical trial NCT03904277: Does Patent Foramen Ovale Size Matter in Men and Women
Official title: Does Patent Foramen Ovale Size Matter in Men and Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Foramen Ovale
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults aged 18-40 with and without a PFO.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: alveolar-arterial difference in oxygen
timeFrame: Baseline
measure: aerobic exercise capacity
timeFrame: Baseline
measure: six-minute walk test
timeFrame: Baseline
measure: minute flow of intrapulmonary areterio-venous anastamoses (QIPAVA)
timeFrame: Baseline
measure: core body temperature
timeFrame: Baseline
measure: level of tumor necrosis factor alpha
timeFrame: Baseline
measure: level of C-C motif cytokine 2
timeFrame: Baseline
measure: level of interferon alpha 2
timeFrame: Baseline
measure: level of interferon gamma
timeFrame: Baseline
measure: level of interleukin 1 beta
timeFrame: Baseline
measure: level of interleukin 6
timeFrame: Baseline
measure: level of interleukin 8
timeFrame: Baseline
measure: level of interleukin 10
timeFrame: Baseline
measure: level of interleukin 12p70
timeFrame: Baseline
measure: level of interleukin 17 alpha
timeFrame: Baseline
measure: level of interleukin 18
timeFrame: Baseline
measure: level of interleukin 23
timeFrame: Baseline
measure: level of interleukin 33
timeFrame: Baseline
measure: level of myoglobin
timeFrame: Baseline
measure: level of myeloid-related protein 8/14
timeFrame: Baseline
measure: level of neutrophil gelatinase-associated lipocalin
timeFrame: Baseline and 3 months post percutaneous closure
measure: level of c-reactive protein
timeFrame: Baseline
measure: matrix metallopeptidase 2
timeFrame: Baseline and 3 months post percutaneous closure
measure: level of osteopontin
timeFrame: Baseline
measure: level of myloperoxidase
timeFrame: Baseline
measure: level of Serum amyloid A
timeFrame: Baseline
measure: level of insulin like growth factor binding protein 4
timeFrame: Baseline
measure: level of intracellular adhesion molecule 1
timeFrame: Baseline
measure: level of vascular cell adhesion protein 1
timeFrame: Baseline
measure: level of metallopeptidase 9
timeFrame: Baseline
measure: level of Cystatin C
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Cardiorespiratory and Pulmonary Physiology Lab
state: Oregon
Study officials:
References: