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临床试验/NCT02837328
NCT02837328已完成2 期

Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias

University of Minnesota1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2017年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
59
试验地点
1
主要终点
Change in Premature Atrial Contractions (PACs)

研究概览

简要总结

The primary objective of this research is to determine whether oral magnesium supplementation in healthy, community-living individuals will be associated with reductions in the burden of arrhythmias in the upper chambers of the heart (supraventricular arrhythmias).

详细描述

To evaluate the primary objective, the Investigator will conduct a double-blind randomized trial assigning participants to receive 400 mg of oral magnesium in the form of magnesium citrate once daily or placebo. The investigators will recruit 60 individuals 55 years of age and older without a prior history of cardiovascular disease. At baseline, participants will undergo a basic examination, answer questionnaires and provide a blood sample to determine circulating magnesium levels. Participants will then wear an FDA-approved heart rhythm monitor (Zio ® XT Patch) for 2 weeks. At the end of 2 weeks they will begin taking their assigned treatment (magnesium or placebo), and will continue doing so for a total of 12 weeks (through study week 14). After 10 weeks of taking the supplement or placebo (study week 12), they will have a final study visit in which the participants will provide another blood sample for assessment of circulating magnesium, and will be asked to wear the heart rhythm monitor for another 2 weeks (through study week 14). The primary endpoint will be the change in burden of premature atrial contractions (PACs), measured in episodes per day, between baseline and final follow-up visit. A secondary outcome will be the change in circulating magnesium between both exams.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age 55 and older
  • Ability to speak English
  • Availability to attend baseline and follow-up visit approximately 12 weeks after baseline

排除标准

  • Prior history of heart disease (coronary heart disease, heart failure, atrial fibrillation), stroke, severe renal disease
  • Use of type I and III antiarrhythmics or digoxin
  • Current use of magnesium supplements
  • Any prior history of allergy or intolerance to magnesium
  • Prior history of inflammatory bowel disease or any severe gastrointestinal disorder

研究组 & 干预措施

Oral Magnesium Supplement

Experimental

400 mg Magnesium Citrate 1x daily for 12 weeks

干预措施: Oral Magnesium Supplement (Drug)

Placebo

Placebo Comparator

Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Premature Atrial Contractions (PACs)

时间窗: Change from Baseline at 10 weeks

The primary endpoint will be the change in burden of PACs

次要结局

  • Change in Magnesium Concentration(Baseline and week 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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