跳至主要内容
临床试验/NCT05066971
NCT05066971尚未招募不适用

Personalized Medicine: Home Monitoring as a Tool to Patient Empowerment. Rate Control Self-adjustment in Patients With Permanent or Persistent Atrial Fibrillation Using Cardiovascular Implantable Electronic Device (CIED) Information

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
2
主要终点
Heart rate control target

研究概览

简要总结

Patients with permanent or persistent atrial fibrillation require rate control medication to prevent excessive tachycardia. Since too much medication leads to a lower than expected heart rate (low output and symptoms) and too little leads to a fast heart rate (with associated symptoms), finding the ideal medication level (target that could fluctuate) is vital for patient's wellbeing. Clinicians adjust the medication each time patients come into the clinic (once or twice a year). In between those visits, medication is not changed even though patients would benefit for some incremental medication adjustment.

Patients implanted with Biotronik devices have access to Home Monitoring® (HM), a user friendly remote monitoring system transmitting daily device and patient information to clinicians. Heart rate and activity hours can be tracked and this information could be used to adjust medication.

In a step by step process, patients will gradually gain autonomy in the weekly adjustment of their rate control medication. In order to guide medication adjustment by patients, the research team will filter and simplify the information received by HM before sending it to patients. It is hypothesize that patient empowerment, understanding the dynamics of their heart rates in relation to the amount of medication used, will lead to better heart rate control, and it will improve the daily hours of patients activity.

详细描述

Patients with permanent or persistent atrial fibrillation require rate control medication to prevent heart rate (HR) speed up. Beta-blockers or calcium channel blockers are used to achieve a reasonable HR; symptoms, EKG and Holter recordings guide clinicians to rate control targets at clinical encounters (at our pacemaker clinic at 6 to 12 months intervals). Once a target HR is achieved, unless new symptoms arise, medication is seldom modified. Rate control medications need to be well adjusted: if not enough dose administered, HR will increase, leading to palpitations, shortness of breath and eventually heart failure; if too much medication is given, patients would experience low cardiac output symptoms (fatigue, tiredness, shortness of breath, low blood pressure, and eventually syncope). Clinicians tend to over control heart rates with no added benefits.

Most of patients with a pacemaker or defibrillator at our center are offered a remote monitoring system as part of a regular follow up schema at our pacemaker clinic; usually to reduce in face encounters, and to be alerted if a problem arises with the pacemaker or defibrillator. There are many remote monitoring systems (five, one for each vendor implanted at our center), and the Home Monitoring® (HM) from Biotronik is specially friendly as all information from the device (pacemaker or defibrillator) is transmitted every day to our clinic with no interaction from the patient side. Beside device status itself (remaining battery, system integrity) daily mean heart rates (measured in beats per minute: bpm) and patient activity (measured as hours per day in activity, as detected by the movement or activity sensor implanted in the device) are also transmitted, but if HR are between safety boundaries (programmed for each patient after implant), all information is rarely used for any other purpose.

If patients with permanent or persistent atrial fibrillation, rate control stable medication, and a HM pacemaker, are followed closely (every week) to adjust the medication (every week if needed, by the research team at the beginning) based on mean heart rates and daily activities already received, we hypothesize that patients will achieve not only better rate control targets, but they will increase their hours of activity per day. Eventually once the patient has understood the principle, medication adjustment would be done by the patient itself based on the same simple information redirected to him or her.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with persistent or permanent atrial fibrillation, on rate control medication stable for at least 6 months
  • patients with a Biotronik pacemaker connected to HM system

排除标准

  • patients with heart failure in need of maximum beta blocker titration
  • patients with other indications that would prevent medication adjustment

结局指标

主要结局

Heart rate control target

时间窗: Through study completion, up to 1 year

Number of weeks where the heart rate is between 80 and 110 beats per minute

6 minutes walk test

时间窗: Baseline, end of the study (12 months after first 6 minute walk test)

Difference in meters walked between first and last 6 minutes walk test

Physical activity during the day

时间窗: Through study completion, up to 1 year

Percentage of physical activity during the day measured by the pacemaker accelerometer at the end of each week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Félix Ayala-Paredes

Cardiologist, electrophysiologist

Université de Sherbrooke

研究点 (2)

Loading locations...

相似试验