The Adjuvant Magnesium Trial (AdMag): Assessment if the Impact of Oral Magnesium on ICD Firing and Quality of Life
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months
研究概览
简要总结
This study is being conducted to see if magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life.
详细描述
Not all ICD shocks are for ventricular arrhythmias. Some patients receive shocks when they have arrhythmias in the atria (top chambers of the heart). These are called inapproriate shocks, but the pain is similar to the pain patients feel with an appropriate shock (a shock for a ventricular arrhythmia). This study is being conducted to determine if taking magnesium can reduce the number of shocks patients with ICDs experience and to see if magnesium supplementation improves patients quality of life. Magnesium's impact of the electrocardiogram (ECG) and intracellular magnesium concentrations will also be studied.
Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the number of ICD shocks and patient perceived quality of life.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly implanted ICD or recent ICD shock (within 6 months) -
排除标准
- •inability to swallow, a non-cardiac disease with a survival prognosis of less than 12 months, hypermagnesemia, a creatinine clearance less than 30mL/min, lactic acidosis or systemic acidosis syndrome, or previous intolerance to magnesium L-lactate.
结局指标
主要结局
Cumulative occurrence of ICD shocks and patient perceived quality of life at baseline, 3,6,9, and 12 months
次要结局
- Change in QTc interval in the total population and the subgroup receiving class III antiarrhythmics at baseline, 3, 6, 9, 12 months.
- Intracellular magnesium concentrations at baseline, 3 and 12 months
- Incidence of supraventricular arrhythmias, ventricular arrhythmias, and sinus tachycardias at baseline, 3,6,9,12 months.
- Ventricular fibrillation cycle length and the variability in VFCL at baseline, 3,6,9,12 months
- Adverse events at basline, 3,6,9,12 months. Total Hospital Costs and Cost-effectiveness.