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

Atrial Fibrillation Clinical Trial

— TriggersAF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05526170
• Other study ID #: TriggersAF
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2022
• Source: Vilnius University
• Contact: Justinas Bacevicius, MD, researcher
• Phone: +37061144646
• Email: justinas.bacevicius100[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Arrhythmias, Cardiac
• Arterial Hypertension
• Atrial Arrhythmia
• Atrial Fibrillation
• Atrial Flutter
• Atrial Premature Complexes
• Atrial Tachycardia
• Caffeine Dependence
• Hypertension
• Parasomnias
• Physical Inactivity
• Premature Atrial Contractions
• Recurrence
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Wake Disorders
• Stress
• Tachycardia

Intervention

Device:
• Devices for long-term monitoring of objective and subjective parameters of the body
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.

Locations

Country	Name	City	State
Lithuania	Vilnius University Santaros Clinics	Vilnius	Vilniaus

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University	Kaunas University of Technology

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Secondary	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	7 days
Secondary	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.	3 months prior to 3 months after inclusion
Secondary	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	7 days
Secondary	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)	7 days
Secondary	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 (%).	3 months prior to 3 months after inclusion.
Secondary	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.	7 days
Secondary	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.	7 days
Secondary	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.	1 day
Secondary	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.	1 day
Secondary	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.	3 months after the collected information is presented to the patient