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临床试验 NCT05526170 (TriggersAF) 针对心房颤动,心房扑动,心房心律失常,心房心动过速,早搏,动脉高血压,睡眠障碍,睡眠呼吸暂停,压力,身体不活动,Overexertion,饮酒,Caffeine Dependence目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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Triggers and Risk Factors for Recurrence of Atrial Arrhythmias With the Use of Long-term Monitoring (TriggersAF)

进行中但不再招募
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临床试验NCT05526170 (TriggersAF)是一项针对心房颤动,心房扑动,心房心律失常,心房心动过速,早搏,动脉高血压,睡眠障碍,睡眠呼吸暂停,压力,身体不活动,Overexertion,饮酒,Caffeine Dependence观察研究试验,目前试验状态为进行中但不再招募。试验始于2021年8月1日,计划招募182名患者。该研究由Vilnius University主导,预计于2024年9月30日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2024年6月26日
简要概括
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.
官方标题

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

疾病
心房颤动心房扑动心房心律失常心房心动过速早搏动脉高血压睡眠障碍睡眠呼吸暂停压力身体不活动Overexertion饮酒Caffeine Dependence
其他研究标识符
  • TriggersAF
NCT编号
实际开始日期
2021-08-01
最近更新发布
2024-06-26
预计完成日期
2024-09-30
计划入组人数
182
研究类型
观察研究
试验状态
进行中但不再招募
关键词
Atrial Fibrillation
Atrial Flutter
Atrial Arrhythmias
Arterial Hypertension
Triggers
Sleep disorders
Sleep apnea
Telemedicine
Mhealth
Remote monitoring
Digital health
试验组/干预措施
参与者组/试验组干预措施/治疗方法
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.
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.
主要终点
结果指标度量标准描述时间框架
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
次要终点
结果指标度量标准描述时间框架
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
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
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
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
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.
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
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
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
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
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
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
  • 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.

  • 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.
Vilnius University logoVilnius University
Kaunas University of Technology logoKaunas University of Technology
没有联系数据。
1 位于 1 个国家/地区的研究中心

Vilniaus

Vilnius University Santaros Clinics, Vilnius, Vilniaus, Lithuania