跳至主要内容
临床试验/NCT05540600
NCT05540600招募中3 期

Left Atrium Reservoir Function Modulation in Patients With Atrial Fibrillation: A Randomized Digoxin Versus Beta Blocker Study

University of Monastir1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
30
试验地点
1
主要终点
Left atrium reservoir strain before and after treatment

研究概览

简要总结

ß blocker and digoxin effect on left atrium reservoir function are unknown. This is a randomized open label study to compare the effect of theses two molecules on left atrium function

详细描述

Atrial fibrillation (AF) is responsible of significant morbidity and mortality. Management of signs and symptoms of heart failure generated by AF is at the center of the latest European recommendations . Mechanisms by which these symptoms are generated are very poorly understood. Heart rate control is one of the recommended strategies but remains poorly codified and generally follows the preferences and experiences of each local center. The European guidelines propose at least 4 molecules for heart rate control without emitting preferences for one molecule over the other due to the lack of robust randomized studies. Recently, a study comparing digoxin vs ß-blockers showed the superiority of digoxin in decreasing symptoms despite a comparable action on heart rate. On the other hand, the reservoir function of the left atrium (LA) has taken a central role in assessing signs of left heart failure and monitoring filling pressures . Other studies have demonstrated the association of left atrium reservoir strain with these symptoms .

It is commonly accepted that ß blockers decrease AF-related symptoms by a negative chronotropic effect thanks to their blocking action on the sympathetic system. While the action of digoxin on symptoms goes through a positive inotropic effect thanks to the increase in intracellular calcium .

However, the impact of these two molecules on the function of the left atrium has never been investigated. Our diagnostic hypothesis is that in addition to their action on heart rate, the improvement of symptoms noted by using b blockers and digoxin during the treatment of AF would go through an improvement LA reservoir function . The superiority of digoxin in the reduction of symptoms compared to ß blockers would be due to a greater improvement in reservoir function and this thanks to the increase in myocardial intracellular calcium.

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
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Any patient with atrial fibrillation naïve to ß-blocker and digoxin or patients followed for Atrial fibrillation and discontinued all treatment for more than a week.
  • •Frequency Control Strategy Decided
  • •Age over 18 years
  • •Stable hemodynamic state
  • •No contraindication to digoxin or ß-blocker

排除标准

  • •Required rhythm control strategy
  • •Contraindication to one of the two
  • •Heart rate <60 BPM
  • •Clearance rénale <30 ml/mn
  • •Pregnant or breastfeeding woman
  • •Persistence of a resting heart rate > 110
  • •Severe comorbidity with decreased life expectancy (advanced neoplasia, large stroke...)

研究组 & 干预措施

Digoxin group

Experimental

Patients will receive digoxin 0.25 mg once daily for a duration of 4 weeks

干预措施: Digoxin 0.25 mg (Drug)

beta blocker group

Experimental

Patients will receive bisoprolol 2.5 mg or 5 m twice a day for a duration of 4 weeks. The choice of dose will depend on blood pressure (BP): If systolic BP ≥ 150 mmHG, the patient will have bisoprolol 5 mg x 2 per day, If systolic BP < 150 mmHG, the patient will have bisoprolol 2.5 mg x 2 per day

干预措施: Bisoprolol (Drug)

结局指标

主要结局

Left atrium reservoir strain before and after treatment

时间窗: 4 weeks

Measurements of Left atrium reservoir strain will be performed at randomization and after 4 weeks on 4 chambers and 2 chamber views according to the most recent recommendations. The acquisition of strain-2D curves will be made by taking as a reference the beginning of the QRS complex. The peak of the curve corresponds to the value of the reservoir strain of the left atrium

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

Nidhal Bouchahda

Principal investigator

University of Monastir

研究点 (1)

Loading locations...

相似试验