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临床试验/NCT06556732
NCT06556732招募中1 期

Potential Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
100
试验地点
1
主要终点
AF recurrence

研究概览

简要总结

This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital on AF patients with structural heart disease. Eplerenone 25 mg daily will be given and searching for AF recurrence among study population.

详细描述

This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital, on 100 patients with AF and structural heart disease. AF is confirmed by electrocardiography. The patients were divided into 2 groups:

Group A (study group): 50 patients received eplerenon 25 mg daily plus amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.

Group B (control group): 50 patients received amiodarone and other medications not including non-dihydropyridine calcium channel blocker or digoxin.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with non-valvular AF who underwent cardioversion to sinus rhythm either medical, electrical or even spontaneously

排除标准

  • Patients with rheumatic heart disease.
  • Thyroid dysfunction.
  • Wolf-Parkinson-White (WPW) syndrome.
  • Renal impairment.
  • Hyperkalemia.
  • Acute coronary syndrome.
  • Pregnancy.
  • Left ventricular (LV) dysfunction with ejection fraction (EF) less than 40%.
  • On current use of eplerenone.

研究组 & 干预措施

Study arm

Experimental

Were given Eplereone 25 mg daily

干预措施: Eplereone (Drug)

Control arm

Placebo Comparator

Were given nothing

干预措施: Eplereone (Drug)

结局指标

主要结局

AF recurrence

时间窗: 6 months

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

Ahmed Abdelgaleel

Professor

Assiut University

研究点 (1)

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