Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Left ventricular mass (by cardiac MRI)
研究概览
简要总结
The objective of this study is to investigate whether nutritional supplementation with magnesium can improve cardiovascular structure and function in participants with obesity - with a long-term goal of preventing clinical heart failure. Specifically, in a randomized open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.
详细描述
The investigators propose a 24-week therapeutic trial involving 40 participants with obesity from the Providence VA Medical Center without clinical heart failure. 20 participants will be treated with 400 mg of Magnesium Oxide twice daily, while 20 participants will receive no treatment. The trial tests the hypothesis that oral Mg supplementation will improve: LV structure (by LV mass, steatosis, and ECV), LV function (systolic and diastolic), vascular health (systolic blood pressure and aortic pulse wave velocity) and visceral adiposity.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index greater than 30 kg/m2
排除标准
- •History of hospitalization for heart failure (systolic or diastolic);
- •Unstable angina or prior myocardial infarction;
- •LV ejection fraction <50% on imaging study;
- •Valvular heart disease (stenosis or insufficiency) greater than moderate degree;
- •Renal dysfunction, serum creatinine >2.5 mg/dL or estimated creatinine clearance <30 mL/min/1.73 m2 (30),
- •Pregnant women or actively breastfeeding women
- •History of drug supplementation within the last 6 months in which more than 50 miliequivalents per day of supplemental magnesium is contained
结局指标
主要结局
Left ventricular mass (by cardiac MRI)
时间窗: 24 weeks
Left ventricular myocardial triglyceride content (by cardiac MRI)
时间窗: 24 weeks
Left ventricular extracellular volume fraction (by cardiac MRI)
时间窗: 24 weeks
次要结局
- Systolic blood pressure(24 weeks)
- Aortic pulse wave velocity (by cardiac MRI)(24 weeks)
研究者
Wen-Chih Wu
Chief of Medicine at the PVAMC and Professor of Medicine at Brown University
Providence VA Medical Center