Role of Magnesium Sulphate as an adjunct to standard practice in patients with Valvular Atrial Fibrillation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- To determine the proportion of successful rate control by intravenous magnesium sulphate along with standard practice as compared to standard practice alone in patients of valvular atrial fibrillation
研究概览
简要总结
Atrial fibrillation presents differently across populations In Western countries it predominantly affects older adults due to age related atrial fibrosis hypertrophy and increased calcium transients in cardiomyocytes
In India however rheumatic heart disease remains the primary cause especially in younger patients RHD leads to mitral valve stenosis causing left atrial dilation fibrosis and electrical remodeling key contributors to AF
This regional variation underscores the need for targeted treatment strategies
Magnesium sulphate a calcium antagonist reduces myocardial excitability by limiting calcium influx making it effective for rate control in AF
Studies have shown that low dose intravenous Magnesium sulphate less than 5g significantly improves heart rate control when used with standard therapy particularly in atrial fibrillation with rapid ventricular response
Meta analyses and clinical trials indicate that Magnesium sulphate enhances rate reduction maintains lower heart rates longercand may accelerate therapeutic response
Given the prevalence of valvular AF in India particularly from RHD this study explores the potential of Magnesium sulphate as an adjunct therapy to improve outcomes in this high risk group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting to the emergency department with valvular atrial fibrillation with fast ventricular rate Age greater than or equal to 18 years Patients / Legally authorised representative willing to give valid consent.
排除标准
- •1.Age below 18 years 2.Systolic blood pressure less than 90 mmHg 3.Atrial fibrillation associated with Wolff-Parkinson-White syndrome 4.Known chronic kidney disease with creatinine clearance below 30 ml/min 5.Presence of acute coronary syndrome 6.Pregnancy 7.Lack of consent from the patient 8.History of chronic malignancy 9.Known allergy to magnesium.
结局指标
主要结局
To determine the proportion of successful rate control by intravenous magnesium sulphate along with standard practice as compared to standard practice alone in patients of valvular atrial fibrillation
时间窗: baseline and 12 hours
次要结局
- 1. To determine the proportion of successful rhythm control by intravenous magnesium sulphate along with standard practice as compared to standard practice alone in patients of valvular atrial fibrillation.(2. To determine the cumulative doses of AV nodal blocking agents required for rate control measure in patients with valvular atrial fibrillation receiving intravenous magnesium sulphate along with standard practice as compared to standard practice alone, until hospital discharge.)
研究者
Siddharth Sai Gunti Mohan
All India Institute of Medical Sciences, New Delhi