NCT02548364已完成3 期
Multicentric, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz7 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 7
- 主要终点
- Change in cardiac remodeling by MRI
研究概览
简要总结
To study the effect of calcifediol on left ventricular remodeling, mineral metabolism, plasma levels of several prognostic biomarkers and on endothelial function after an anterior myocardial infarction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years and maximum 85 years.
- •Anterior myocardial infarction
- •Sign informed consent
排除标准
- •Death during the index event
- •Age younger than 40 or older than 85 years
- •Previous Infarction
- •More than 7 days in hospitalization
- •Systemic inflammatory or autoimmune disease
- •Concomitant disorders limiting survival
- •Concomitant cardiomyopathy
- •Left ventricular hypertrophy > 16mm in females and > 17mm in males
- •Incomplete revascularization
- •Valvular prosthesis
- •Aortic stenosis with mean gradient> 25 mmHg
- •Moderate or severe valvular regurgitation
- •Hypersensitivity or intolerance vitamin D supplement o excipient
- •Blood Calcium >10.5 mg/dl
- •Inability to follow.
- •Difficulty in treatment compliance
- •Contraindication for MRI, including indication to place a cardiac device
- •Indication of therapy with vitamin D. Patient desires to take vitamin D.
- •Drugs or conditions that interfere with the pharmacokinetics of calcifediol
研究组 & 干预措施
Calcifediol
Experimental
One capsule with 15,690 IU p.o. every two weeks
干预措施: Calcifediol (Drug)
Placebo
Placebo Comparator
One capsule with placebo p.o. every two weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in cardiac remodeling by MRI
时间窗: 1 year
It is a composite outcome measure. It will be analyzed by measuring the following parameters: myocardium at risk, size of infarcted myocardium, saved myocardium, ejection fraction, left ventricular telesystolic and telediastolic volumes
次要结局
- Change in echocardiographic parameters(1year)
- Change in mineral metabolism parameters(1 year)
- Change in prognostic biomarkers levels(1 year)
- Change in lipid levels(1 year)
- Change in flow mediated vasodilation(1 year)
- Adverse event rate(1.5, 3, 6, 9, 12 and 13 months)
- % of treatment compliance(3, 6, 9 and 12 months)
研究者
研究点 (7)
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