Atrial Electromechanical Function in Endurance Athletes With and Without Atrial Fibrillation

November 2, 2020 updated by: Emily Vecchiarelli, University of Toronto

Atrial Electromechanical Function in Middle-aged Endurance Athletes With and Without Atrial Fibrillation

This study evaluates cardiac structure and function differences between healthy endurance trained athletes with atrial fibrillation and healthy age matched endurance trained athletes without atrial fibrillation. It is hypothesized that despite having similar structural adaptations of the heart (due to endurance training), athletes with atrial fibrillation display will impaired heart functional measures compared to endurance athletes without atrial fibrillation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Regular physical activity, including vigorous exercise, lowers cardiovascular risk factors, including the risk of developing Atrial Fibrillation (AF), one of the most commonly diagnosed types of arrhythmias. Paradoxically, despite the cardioprotective effects of exercise, middle aged endurance athletes are at 5 fold risk of developing AF compared to active individuals. Long standing endurance training induces significant changes to the heart- collectively known as the 'athlete's heart.' While these changes may be beneficial for performance, they may be conducive in promoting the risk of AF in this cohort. The aim of this study is to compare cardiac structure and function in endurance athletes diagnosed with AF (n=17) and in healthy aged matched endurance athletes (n=17). Male subjects between ages 45 and 65 years old with a long-standing history of endurance training and competition will be recruited. Heart structure and function will be compared at rest and during submaximal exercise. Participants will also complete fitness assessments and questionnaires that characterize their lifetime involvement in exercise training. This study will address the gap in the literature regarding the interaction of endurance training and AF risk.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 2C9
        • Goldring Center for High Performance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Community sample from, but not limited to, various running, cycling, and rowing clubs for middle-aged athletes. Healthy endurance athletes will be selected from an existing study for convenience (non-probability sample). Endurance athletes with AF will be selected from the community (probability sample).

Description

Inclusion Criteria:

ALL participants:

  • endurance athlete (cyclist, runner, triathlete or other) who participate in vigorous year-round training of 4-6 hours per week for a minimum of 20 years
  • participation in atleast one major competition per year (marathon/triathlon/endurance competition)
  • sinus rhythm during all assessments

Inclusion criteria specific to endurance athletes with AF:

  • diagnosed with lone paroxysmal AF in the last 4 years
  • able to verify diagnosis (ECG or Holter verification/proof of diagnosis),
  • can be on any type of medication.

Inclusion criteria specific to healthy endurance athletes without AF:

  • previous participation in Athlete's Heart Study
  • has completed resting cardiac magnetic resonance imaging and resting electrocardiogram

Exclusion Criteria:

  • females
  • no more than >1 hour per week of resistance training
  • treatment or prior diagnosis of cardiovascular disease, valvular disease, hypertension, heart failure, diabetes, thyroid disorder, sleep apnea, current/recent viral disease, chronic inflammatory disease
  • previous (within 10 years) or current smoking
  • recreational drug use or alcohol consumption in excess of accepted standards
  • inability to provide informed consent
  • inability to verify AF diagnosis (if AF athlete).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Endurance Athlete with Atrial Fibrillation
These are middle-aged athletes who are diagnosed with paroxysmal Atrial Fibrillation in the last 4 years, but are otherwise free of disease.
Endurance Athlete without Atrial Fibrillation
These are middle-aged athletes who will serve as our control group- they have not been diagnosed with AF or any other disease.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Left intra-atrial electromechanical delay (ms)
Time Frame: baseline (day 1: at first visit, one time measure)
Left intra-atrial electromechanical delay will be measured using cardiac echocardiography at rest and during submaximal cycling. Left intra-atrial electromechanical delay will be measured as the time interval between the initiation of the P wave (on an electrocardiogram) to the beginning of the late diastolic wave (Am wave) on echocardiography.
baseline (day 1: at first visit, one time measure)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Left atrial reservoir function
Time Frame: baseline (day 1: at first visit, one time measure)
Left atrial reservoir function will be measured by Speckle Tracking echocardiography, at 60-80 frames per second. Left atrial reservoir function will be measured by assessing left atrial reservoir strain (%), measured during ventricular systole on echocardiography.
baseline (day 1: at first visit, one time measure)
Left atrial volume (mL)
Time Frame: baseline (day 1: at first visit, one time measure)
Left atrial volume (mL) will be measured using echocardiography at the end of ventricular systole, prior to the opening of the mitral valve. Imaging will be acquired using two and four chamber views.
baseline (day 1: at first visit, one time measure)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lifetime hours of Physical Activity (# of hours)
Time Frame: baseline (day 1: at first visit, one time measure)
Total lifetime hours of physical activity will be assessed using the Lifetime Physical Activity Questionnaire (LTPAQ).
baseline (day 1: at first visit, one time measure)
Maximal oxygen consumption (VO2 max)
Time Frame: baseline (day 1: at first visit, one time measure)
Maximal oxygen consumption (VO2 max) will be determined using a maximal treadmill test, in which a calibrated metabolic cart and indirect calorimetry will be used. VO2 max will be expressed as ml/kg/min.
baseline (day 1: at first visit, one time measure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Unity Health Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Dorian, MD, Unity Health Toronto
  • Principal Investigator: Emily Vecchiarelli, BKin, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AthletesHeartUofT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Participant data may be used for future study upon participant consent for their de-identified data to be used in the event that a related study is conducted. Only principal investigators will have access to records and will have the ability to share data with approved researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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