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Atrial FibrillationTriggersAFNCT05526170

Triggers and Risk Factors for Recurrence of Atrial Arrhythmias With the Use of Long-term Monitoring

An observational study of Atrial Fibrillation and Atrial Flutter, run by Vilnius University at 1 site in Lithuania.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Devices for long-term monitoring of objective and subjective parameters of the body
Type of treatment
Medical device
How many people
182 participants
Where
1 siteLithuania
Study dates
1 Aug 2021to 30 Sep 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time.

Who may be able to join

  • Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time.
  • An informed consent is signed by the patient.

Who cannot join

  • The qualifying episode of AF has never been documented in ECG or Holter ECG monitoring.
  • Patients with atrial fibrillation, atrial flutter or atrial tachycardia at inclusion time.
  • Patients with permanent atrial fibrillation or permanent atrial flutter.
  • Age <18 years.
  • Patients with a pacemaker or an implanted cardiovert-defibrillator.
  • Patients suffering from dementia or other severe neurological disorders and thus incapable to participate.
  • Patients who present with antisocial behavior and/or do not want to participate in the study.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site
  • Vilnius University Santaros Clinics

    Vilnius, Vilniaus

Other trials in Lithuania

About this study

Official title: Personalized Detection of Triggers and Risk Factors for Recurrence of Atrial Fibrillation and Other Atrial Arrhythmias With the Use of Long-term Monitoring

A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.

Being tested
Devices for long-term monitoring of objective and subjective parameters of the body
Keywords
Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmias, Arterial Hypertension, Triggers, Sleep disorders, Sleep apnea, Telemedicine, Mhealth, Remote monitoring, Digital health
Medical subject headings
Atrial Fibrillation, Atrial Flutter, Atrial Premature Complexes, Hypertension, Sleep Wake Disorders, Sleep Apnea Syndromes, Sedentary Behavior, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Devices for long-term monitoring of objective and subjective parameters of the bodyDevice

    Patients will use a 1-lead Holter ECG (Bittium Faros) for heart rhythm and physical activity analysis, a wearable wrist-worn device with photoplethysmography and 6-lead ECG for heart rhythm analysis, a sleep tracking mat (Withings sleep analyser) for sleep analysis, a smartphone with triggers application for entering the subjective triggers (stress, coffee, alcohol intake and others), a 48-hour ambulatory blood pressure monitor for 2 days and a regular blood pressure monitor for up to 5 days. Patients will be monitored for up to 7 days with the described system of devices. In addition, patients will receive investigations of heart echocardiography, laboratory tests and surveys to evaluate the system and the use of acquired information.

Study groups in NCT05526170
Study groupRoleWhat they receive
Patients with previously diagnosed paroxysmal or persistent atrial fibrillationPatients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time. During trial period subjects will be monitored for different atrial arrhythmias and divided into the following subgroups: atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions (bigeminy, trigeminy, couplets), multiple atrial arrhythmias and no arrhythmia detected.
Receives: Device: Devices for long-term monitoring of objective and subjective parameters of the body

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure association with atrial arrhythmias in patients with previously diagnosed atrial fibrillation

    Patterns of blood pressure fluctuations in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days. An association between episodes of uncontrolled arterial hypertension and occurrence of arrhythmia episodes is anticipated.

    Measured: 7 days

Secondary outcomes (10)
  1. Association of various triggers with atrial arrhythmias in patients with previously diagnosed atrial fibrillation

    Patterns of distinct triggers in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days. Mobile application and accelerometer of Holter ECG device will be used to record these factors as well as mark the time and the frequency of these actions. Attempts will be made to link all patient-marked triggers, their frequency, time of onset to the occurrence of arrhythmia.

    Triggers such as:

    coffee intake alcohol consumption distinguished by strength into:

    • spirits: brandy, vodka,
    • vine or champagne
    • low alcohol drinks: beer, cider emotional stress, overeating, physical activity, strenuous exercise, cold food, cold drink, lack of sleep other activities or things participants feel are related to the onset of arrhythmias

    Measured: 7 days

  2. Association of available blood tests results to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation

    Blood tests may be useful in determining the effect of concomitant illness, their exacerbations, or, conversely, the stable course of the disease on the arrhythmia.

    Available results of each separate test (potassium, sodium, magnesium, BNP, creatinine, glomerular filtration rate, lipid profile, c-reactive protein) in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a period of 3 months prior to 3 months after inclusion.

    Measured: 3 months prior to 3 months after inclusion

  3. Association of sleep analysis data with atrial arrhythmias in patients with previously diagnosed atrial fibrillation

    Each participant will be given a sleeping mat to put under the mattress and data collected from it in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days.

    Measured separately as:

    Sleep Quality Index, Apnea Episodes, Snoring Episodes, Snoring (%), Sleep Duration (Hours), Regular Sleep, Sleep Depth, Sleep Breaks

    Measured: 7 days

  4. Temporal relation between changes in blood pressure and atrial arrhythmias in patients with previously diagnosed atrial fibrillation

    The results from the 48-hour blood pressure measurements (ambulatory BPM Mobil-o-graph's data) and additional 5 days measurements (Withings BPM) will be used to describe temporal relation between changes in blood pressure and atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days. The temporal relation will be measured as a time of blood pressure rise/fall before arrhythmia occurrence personalized for each individual and generalized for groups of individuals.

    Collected data:

    date, time, systole mean arterial pressure, Diastole, Peripheral pulse pressure (pPP), Heart rate (Hr), cSPB, cDBP, MAP-C2 (calibration for calculating the aortic central systolic blood pressure)

    Measured: 7 days

  5. Association of echocardiographic results to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation

    Echocardiography parameters will show cardiac status and function: chambers sizes, presence of left ventricular (LV) hypertrophy, atrial enlargement; the strains of left atrium and the predicted risk of these parameters in relation to atrial arrhythmias. Echocardiography will be acquired within a period of 3 months prior to 3 months after inclusion.

    Echocardiography parameters: Main: LV ejection fraction (LV EF) (%), LV end diastolic diameter (LVdd) (cm), Interventricular septal diameter (IVd) (cm), LV posterior wall diameter (LVPWd) (cm), E and A waves (m/s), Left atrial diameter (cm), LA volume index (ml/m2), LA maximum volume (ml), E' lat, E' med (cm/s), E' vid, E/e' vid, E deceleration time (ms). Additional parameters (%): mean contractile strain, 4 chamber (4 CH) contractile strain, 2 CH contractile strain, mean conduit strain, 4 CH conduit strain, 2 CH conduit strain, mean reservoir strain (%), 4 CH reservoir strain (%), 2 CH reservoir strain (%).

    Measured: 3 months prior to 3 months after inclusion.

  6. Association of parasympathetic and sympathetic tone to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation

    The activity of autonomic nervous system will be measured as heart rate variability (HRV), standard deviation of normal-to-normal heart rate intervals (SDNN) and other parameters in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days.

    Measured: 7 days

  7. Association of physical activity to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation

    To assess level of physical activity (measured as MET and the number of steps taken per day) in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days.

    Measured: 7 days

  8. Potential triggers named by participants, symptoms, burden of arrhythmia and the quality of life in patients with previously diagnosed atrial fibrillation before monitoring

    Before the start of monitoring participants will fill out the questionnaire of most frequent known triggers, which could provoke their arrhythmias as well as mark the arrhythmia-related symptoms and the burden of arrhythmia in everyday life.

    Measured: 1 day

  9. Usability of devices in everyday use

    After the monitoring of 7 days participants will fill out the questionnaire of the convenience of each device and the willingness to use them if recommended by a physician in everyday practice.

    Measured: 1 day

  10. Potential triggers named by participants, symptoms, burden of arrhythmia and the quality of life in patients with previously diagnosed atrial fibrillation after the collected information is presented to the patients

    At least 3 months after the collected monitoring results are presented to the patients, the participants will fill out the questionnaire about changes of perceived potential triggers, symptoms, burden of arrhythmia and the quality of life ad symptoms.

    Measured: 3 months after the collected information is presented to the patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start1 Aug 2021
  3. Primary completion15 Jul 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05526170
Sponsor's protocol ID
TriggersAF
Acronym
TriggersAF
Status last verified
Jun 2024
First submitted
17 Feb 2022
Last updated
26 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Atrial Flutter, run by Vilnius University at 1 site in Lithuania.

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 7 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. 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 Lithuania. 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?

Results are not available in the source record.

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?

Blood pressure association with atrial arrhythmias in patients with previously diagnosed atrial fibrillation (time frame: 7 days). 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 26 Jun 2024.

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