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临床试验/NCT03186976
NCT03186976已完成不适用

Reversal of Atrial Substrate to Prevent Atrial Fibrillation - A Pilot Study

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
adherence to the risk factor intervention

研究概览

简要总结

This is a pilot study to assess feasibility to conduct a multi-center, randomized trial to examine the effect of aggressive risk factor control and arrhythmia trigger-based intervention on the atrial substrate, which is involved in the development and maintenance of atrial fibrillation (AF).

详细描述

Atrial fibrillation (AF) is a major health problem, with a prevalence of 0.4-1% of the population. It is associated with a six-fold risk of stroke and a two-fold increase in mortality, the main cardiac reason for death one year after presenting to the emergency department with AF is heart failure. It results in high healthcare costs, recurrent ED visits and hospitalizations. The burden of disability associated with AF has been found to increase by 20% from 1990-2010. AF was also cited as one of the seven causes of death that has been increasing worldwide. Prevention of AF has not been a focus of past treatments and it is well known that elevated body mass index, hypertension, smoking, increased alcohol intake, lack of exercise and sleep apnea are risk factors for AF. There is a lack of randomized, multicenter data proving that a strategy of aggressive risk factor modification will prevent and modify AF.

Upstream therapy for AF has been of considerable interest, and benefit has been demonstrated in primary prevention of AF. Catheter ablation has demonstrated success over current medical therapies for long-term rhythm control, but recurrence remains high, irrespective of ablation strategy. This study is a feasibility study to determine whether a complex and multi-component risk factor modification can be successfully implemented.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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 symptomatic (CCS-SAF ≥2) recurrent paroxysmal or persistent nonvalvular atrial fibrillation despite rate control, desiring catheter ablation AND
  • one of : BMI>27, BP>140/90 or history of hypertension, alcohol use > recommended limit, current smoking, diabetes with HgA1C>7%, physical inactivity (<150 minutes/week).
  • (Definitions: Recurrent paroxysmal - at least 4 episodes of symptomatic AF in the prior 6 months, with or without cardioversion; Persistent AF lasting greater than 7 days but less than 3 years; AF must be documented on a Holter, rhythm strip or electrocardiogram within the last 24 months.)

排除标准

  • Permanent AF (AF lasting > 3 years)
  • Prior catheter ablation for AF
  • Left ventricular ejection fraction <30%
  • Left atrial size > 5.5 cm
  • NYHA IV heart failure
  • Participation in a cardiac rehabilitation program within the last year
  • Currently performing exercise training 150 minutes/week of moderate to vigorous physical activity
  • Unable to exercise
  • Unable to give informed consent
  • Other noncardiovascular medical condition making 1 year survival unlikely

结局指标

主要结局

adherence to the risk factor intervention

时间窗: 6 months

80% compliance to each of the components: 150 minutes exercise/week, BP target as per CHEP guidelines, alcohol limits, smoking cessation, and sleep apnea therapy, hemoglobin A1C\<6.5% at the end of follow up. If 80% of individuals can reach these 80% of the time, the adherence criteria will be met.

次要结局

  • Feasibility of recruitment(6 months)

研究者

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

Ratika Parkash

MD, FRCPC

Nova Scotia Health Authority

研究点 (2)

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