EUCTR2006-006863-22-GB进行中(未招募)1 期
Role of Poly Unsaturated Fatty Acids (PUFAs) in the management of Paroxysmal Atrial Fibrillation (PAF) - PUFA-PAF STUDY
niversity Hospital of South Manchester NHS Foundation Trust0 个研究点目标入组 100 人开始时间: 2007年8月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •All patients who have PAF and a dual chamber pacemaker, who have shown an AF burden of =10% in the most recent pacing check and are not symptomatic from it.
- •New Criteria as per '2006/CD/013-VERSION-2-10/05/2007' substantial amendment.
- •The inclusion criteria specifies a very high rate of paroxysmal atrial fibrillation
- •which is not necessary to show a difference. As the difference to be perceived is a percentage of the burdena realistic AF burden ( reflecting the clinical occurrence of Af in these patients) would enable us to recruit more patients with out influencing the significance of the difference that would be seen betwenn the active and the placebo group. Hence we wish to change the inclusion criteria relating to the Af burden to > or =3% Af burden to > or = 3%
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with persistent atrial fibrillation.
- •Patients who are already on class-1 or class-3 anti-arrhythmic therapy.
- •Patients who have been taking omega-3 supplements or have done so within a three month period preceding enrolment.
研究者
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