Does Patent Foramen Ovale Size Matter in Men and Women

NCT03904277 | Completed

• 1 other identifier: 04302018.049
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Patent Foramen Ovale

Outcome Measures

Primary Outcomes (31)

• alveolar-arterial difference in oxygen

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

  Baseline

• aerobic exercise capacity

  ability to utilize oxygen while exercising, AKA Vo2MAX

  Baseline

• six-minute walk test

  distance covered in 6 minutes of walking

  Baseline

• minute flow of intrapulmonary areterio-venous anastamoses (QIPAVA)

  minute flow through intrapulmonary arteriovenous anastamoses

  Baseline

• core body temperature

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

  Baseline

• level of tumor necrosis factor alpha

  inflammatory marker

  Baseline

• level of C-C motif cytokine 2

  inflammatory marker

  Baseline

• level of interferon alpha 2

  inflammatory marker

  Baseline

• level of interferon gamma

  inflammatory marker

  Baseline

• level of interleukin 1 beta

  inflammatory marker

  Baseline

• level of interleukin 6

  inflammatory marker

  Baseline

• level of interleukin 8

  inflammatory marker

  Baseline

• level of interleukin 10

  inflammatory marker

  Baseline

• level of interleukin 12p70

  inflammatory marker

  Baseline

• level of interleukin 17 alpha

  inflammatory marker

  Baseline

• level of interleukin 18

  inflammatory marker

  Baseline

• level of interleukin 23

  inflammatory marker

  Baseline

• level of interleukin 33

  inflammatory marker

  Baseline

• level of myoglobin

  inflammatory marker

  Baseline

• level of myeloid-related protein 8/14

  inflammatory marker

  Baseline

• level of neutrophil gelatinase-associated lipocalin

  inflammatory marker

  Baseline and 3 months post percutaneous closure

• level of c-reactive protein

  inflammatory marker

  Baseline

• matrix metallopeptidase 2

  inflammatory marker

  Baseline and 3 months post percutaneous closure

• level of osteopontin

  inflammatory marker

  Baseline

• level of myloperoxidase

  inflammatory marker

  Baseline

• level of Serum amyloid A

  inflammatory marker

  Baseline

• level of insulin like growth factor binding protein 4

  inflammatory marker

  Baseline

• level of intracellular adhesion molecule 1

  inflammatory marker

  Baseline

• level of vascular cell adhesion protein 1

  inflammatory marker

  Baseline

• level of metallopeptidase 9

  inflammatory marker

  Baseline

• level of Cystatin C

  inflammatory marker

  Baseline

Study Arms (3)

No PFO

Research subjects who present no evidence of PFO - IE no appearance of saline contrast microbubbles within 3 cardiac cycles

Small PFO

Research subjects who present evidence of having a small PFO or ASD - IE appearance of 1-11 saline contrast microbubbles within 3 cardiac cycles

Large PFO

Research subjects who present evidence of having a large PFO - IE appearance of 12+ saline contrast microbubbles within 3 cardiac cycles.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adults aged 18-40 with and without a PFO.

You may qualify if:

• Men and women aged 18-40
• Known to have/not have a PFO.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of Oregon: lead

Study Sites (1)

Cardiorespiratory and Pulmonary Physiology Lab

Eugene, Oregon, 97403, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma from venous blood sample

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 5, 2019
• Study Start: October 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: January 25, 2023
• Last Updated: February 1, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)