Supraventricular ArrhythmiasFA2VNCT03665324
Atrial Function and Supraventricular Arrhythmia of the Veteran Athlete.
An observational study of Supraventricular Arrhythmias, run by Rennes University Hospital at 1 site in France.
Trial summary
Supraventricular arrhythmias (including atrial fibrillation) are the most common arrhythmias of the veteran athlete and have a major impact in terms of morbidity and mortality. Although moderate sports practice has been shown to decrease the occurrence of these arrhythmias, it has also been shown that very intense… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Supraventricular Arrhythmias
- What is being tested?
- Evaluation of the relationship between atrial remodeling evaluated by ECG and ETT with the occurrence of supraventricular arrhythmias
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2017to 15 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Adult, Older adult
Study population: Veteran athletes who consulted in the Sports Medicine Department between January 1, 2010 and January 1, 2017
Who may be able to join
- Supraventricular arrhythmia group : Veteran athletes with documented paroxysmal supraventricular arrhythmias.
- Control Group : Veteran athletes without documented supraventricular arrhythmia.
Who cannot join
- Any cardiopathy (valvulopathy, coronary heart disease, etc.).
- Minor patients,
- Major patients subject to legal protection (legal safeguards, guardianship)
- Persons deprived of their liberty
- Patients opposed to the use of their personal data.
Trial locations and contacts
1 site in 1 country.
About this study
Supraventricular arrhythmias (including atrial fibrillation) are the most common arrhythmias of the veteran athlete and have a major impact in terms of morbidity and mortality. Although moderate sports practice has been shown to decrease the occurrence of these arrhythmias, it has also been shown that very intense athletic activity is associated with an increased risk of developing atrial fibrillation. The pathophysiological mechanism is not clearly understood. However, it has already been shown that intensive sports practice leads to electrical and morphological atrial remodeling, which could be the cause of the occurrence of supraventricular arrhythmias for these athletes.
For sedentary patients, two major tools predict the risk of the onset of supraventricular arrhythmia: the electrocardiogram (ECG) and transthoracic echocardiography (ETT), particularly with the study of atrial function by the analysis of myocardial deformities.
Read the detailed description
No studies have tested these two tools for the evaluation of atrial remodeling of the veteran athlete to predict which ones are at risk of developing supraventricular arrhythmias.
However, the identification of predictive factors would make it possible to identify at-risk athletes and thus provide them with adapted sporting practice advice and personalized follow-up.
The aim of the study is to evaluate the relationship between atrial remodeling assessed by ECG and ETT with the occurrence of supraventricular arrhythmia by comparing an athlete group with supraventricular arrhythmia with a control group of healthy athletes.
- Conditions
- Supraventricular Arrhythmias
- Being tested
- Evaluation of the relationship between atrial remodeling evaluated by ECG and ETT with the occurrence of supraventricular arrhythmias
- Keywords
- Supraventricular arrhythmias, veteran athlete, ECG, ETT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the relationship between atrial remodeling evaluated by ECG and ETT with the occurrence of supraventricular arrhythmiasOther
Subjects will be retrospectively retrieved from the Sport Medicine Service of Rennes University Hospital database.
Medical data will then be collected from the athletes' medical records. The ECG present in the medical file will be reinterpreted to obtain the resting heart rate, the amplitude of the P wave, the morphology of the P wave and the duration of the PR space.
The data from the stress test will be found from reports in the medical records: resting heart rate, maximum heart rate, sustained peak load, arrhythmia during the test.
ETTs will be retrieved from the local server. They will be reinterpreted to collect anatomical and functional cardiac data necessary for the study.
| Study group | Role | What they receive |
|---|---|---|
| Veteran athletes with Supraventricular arrhythmias | Subjects who consulted in the Sports Medicine Department between January 1, 2010 and January 1, 2017 Veteran athletes (age> 35 years) with documented paroxysmal supraventricular arrhythmias. Receives: Other: Evaluation of the relationship between atrial remodeling evaluated by ECG and ETT with the occurrence of supraventricular arrhythmias | |
| Veteran athletes without supraventricular arrhythmia | Subjects who consulted in the Sports Medicine Department between January 1, 2010 and January 1, 2017 Veteran athletes (age> 35 years) without documented supraventricular arrhythmia. Receives: Other: Evaluation of the relationship between atrial remodeling evaluated by ECG and ETT with the occurrence of supraventricular arrhythmias |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of atrial function by analysis of myocardial strain.
Myocardial strain in extracted from ETT and compared between the two groups.
Measured: At the inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start28 Apr 2017
- Primary completion15 May 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraventricular ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- frederic SCHNELL, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665324
- Sponsor's protocol ID
- 35RC17_3066
- Acronym
- FA2V
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Function and Supraventricular Arrhythmia of the Veteran Athlete.
- ClinicalTrials.gov ID
- NCT03665324
- Acronym / sponsor ID
- FA2V / 35RC17_3066
- Conditions
- Supraventricular Arrhythmias
- Keywords
- Supraventricular arrhythmias, veteran athlete, ECG, ETT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Supraventricular arrhythmias (including atrial fibrillation) are the most common arrhythmias of the veteran athlete and have a major impact in terms of morbidity and mortality. Although moderate sports practice has been shown to decrease the occurrence of these arrhythmias, it has also been shown that very intense athletic activity is associated with an increased risk of developing atrial fibrillation. The pathophysiological mechanism is not clearly understood. However, it has already been shown that intensive sports practice leads to electrical and morphological atrial remodeling, which could be the cause of the occurrence of supraventricular arrhythmias for these athletes.
For sedentary patients, two major tools predict the risk of the onset of supraventricular arrhythmia: the electrocardiogram (ECG) and transthoracic echocardiography (ETT), particularly with the study of atrial function by the analysis of myocardial deformities.
Detailed description
No studies have tested these two tools for the evaluation of atrial remodeling of the veteran athlete to predict which ones are at risk of developing supraventricular arrhythmias.
However, the identification of predictive factors would make it possible to identify at-risk athletes and thus provide them with adapted sporting practice advice and personalized follow-up.
The aim of the study is to evaluate the relationship between atrial remodeling assessed by ECG and ETT with the occurrence of supraventricular arrhythmia by comparing an athlete group with supraventricular arrhythmia with a control group of healthy athletes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veteran athletes with Supraventricular arrhythmias | – | Other: Evaluation of the relationship between atrial remodeling evaluated by ECG and ETT with the occurrence of supraventricular arrhythmiasSubjects who consulted in the Sports Medicine Department between January 1, 2010 and January 1, 2017 Veteran athletes (age> 35 years) with documented paroxysmal supraventricular arrhythmias. |
| Veteran athletes without supraventricular arrhythmia | – | Other: Evaluation of the relationship between atrial remodeling evaluated by ECG and ETT with the occurrence of supraventricular arrhythmiasSubjects who consulted in the Sports Medicine Department between January 1, 2010 and January 1, 2017 Veteran athletes (age> 35 years) without documented supraventricular arrhythmia. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Veteran athletes who consulted in the Sports Medicine Department between January 1, 2010 and January 1, 2017
Key inclusion criteria (2 listed)
- Supraventricular arrhythmia group : Veteran athletes with documented paroxysmal supraventricular arrhythmias.
- Control Group : Veteran athletes without documented supraventricular arrhythmia.
Key exclusion criteria (5 listed)
- Any cardiopathy (valvulopathy, coronary heart disease, etc.).
- Minor patients,
- Major patients subject to legal protection (legal safeguards, guardianship)
- Persons deprived of their liberty
- Patients opposed to the use of their personal data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the relationship between atrial remodeling evaluated by ECG and ETT with the occurrence of supraventricular arrhythmiasSubjects will be retrospectively retrieved from the Sport Medicine Service of Rennes University Hospital database. Medical data will then be collected from the athletes' medical records. The ECG present in the medical file will be reinterpreted to obtain the resting heart rate, the amplitude of the P wave, the morphology of the P wave and the duration of the PR space. The data from the stress test will be found from reports in the medical records: resting heart rate, maximum heart rate, sustained peak load, arrhythmia during the test. ETTs will be retrieved from the local server. They will be reinterpreted to collect anatomical and functional cardiac data necessary for the study. | Other | Veteran athletes with Supraventricular arrhythmias, Veteran athletes without supraventricular arrhythmia |
Primary outcome
Study of atrial function by analysis of myocardial strain.
Time frame: At the inclusion day
Myocardial strain in extracted from ETT and compared between the two groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
frederic SCHNELL, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraventricular Arrhythmias, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of atrial function by analysis of myocardial strain. (time frame: At the inclusion day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.