Clinical trial NCT05526170: Triggers and Risk Factors for Recurrence of Atrial Arrhythmias With the Use of Long-term Monitoring
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Atrial Flutter
Atrial Arrhythmia
Atrial Tachycardia
Premature Atrial Contractions
Arterial Hypertension
Sleep Disorder
Sleep Apnea
Stress
Physical Inactivity
Overexertion
Alcohol Drinking
Caffeine Dependence
Keywords: Atrial Fibrillation
Atrial Flutter
Atrial Arrhythmias
Arterial Hypertension
Triggers
Sleep disorders
Sleep apnea
Telemedicine
Mhealth
Remote monitoring
Digital health
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Kaunas University of Technology
First posted: 2022-09-02
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time.

Brief 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. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Blood pressure association with atrial arrhythmias in patients with previously diagnosed atrial fibrillation
timeFrame: 7 days
Secondary outcomes:
measure: Association of various triggers with atrial arrhythmias in patients with previously diagnosed atrial fibrillation
timeFrame: 7 days
measure: Association of available blood tests results to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
timeFrame: 3 months prior to 3 months after inclusion
measure: Association of sleep analysis data with atrial arrhythmias in patients with previously diagnosed atrial fibrillation
timeFrame: 7 days
measure: Temporal relation between changes in blood pressure and atrial arrhythmias in patients with previously diagnosed atrial fibrillation
timeFrame: 7 days
measure: Association of echocardiographic results to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
timeFrame: 3 months prior to 3 months after inclusion.
measure: Association of parasympathetic and sympathetic tone to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
timeFrame: 7 days
measure: Association of physical activity to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
timeFrame: 7 days
measure: Potential triggers named by participants, symptoms, burden of arrhythmia and the quality of life in patients with previously diagnosed atrial fibrillation before monitoring
timeFrame: 1 day
measure: Usability of devices in everyday use
timeFrame: 1 day
measure: 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
timeFrame: 3 months after the collected information is presented to the patient
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Santaros Clinics
state: Vilniaus
Study officials:
References: