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

NCT05526170 | Active Not Recruiting DMC

• 1 other identifier: TriggersAF
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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.

  7 days

Secondary Outcomes (10)

• Association of various triggers with atrial arrhythmias in patients with previously diagnosed atrial fibrillation

  7 days

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

  3 months prior to 3 months after inclusion

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

  7 days

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

  7 days

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

  3 months prior to 3 months after inclusion.

Study Arms (1)

Patients with previously diagnosed paroxysmal or persistent atrial fibrillation

Patients 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.

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

Interventions

Devices for long-term monitoring of objective and subjective parameters of the body DEVICE

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.

Patients with previously diagnosed paroxysmal or persistent atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• An informed consent is signed by the patient.

You may not qualify if:

• The qualifying episode of AF has never been documented in ECG or Holter ECG monitoring.
• 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.

Sponsors & Collaborators

• Vilnius University: lead
• Kaunas University of Technology: collaborator

Study Sites (1)

Vilnius University Santaros Clinics

Vilnius, Vilniaus, Lithuania

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Atrial Premature Complexes; Hypertension; Sleep Wake Disorders; Sleep Apnea Syndromes; Sedentary Behavior; Alcohol Drinking

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature; Cardiac Conduction System Disease; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Drinking Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: September 2, 2022
• Study Start: August 1, 2021
• Primary Completion: July 15, 2024
• Study Completion: September 30, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

LI (1)