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临床试验/NCT01461733
NCT01461733已完成4 期

Atrial Fibrillation WITHOUT Hemodynamic Stability

Ottawa Hospital Research Institute0 个研究点目标入组 25 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
25
主要终点
Conversion From Atrial Fibrillation to Sinus Rhythm

研究概览

简要总结

Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate.

The objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function.

详细描述

see above

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

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

  • new onset afib

排除标准

  • hemodynamically unstable

研究组 & 干预措施

amiodarone

Experimental

standard dose amiodarone

干预措施: amiodarone (Drug)

placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Conversion From Atrial Fibrillation to Sinus Rhythm

时间窗: From randomization to conversion or ICU discharge up to 100 months.

Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.

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

S. Kanji

MD

Ottawa Hospital Research Institute

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