Study of the Effect of Calcifediol Supplementation on Left Ventricular Function in Cardiopathic Patients Undergoing Major Orthopedic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Evaluation of improvement of ejection fraction (FE)
研究概览
简要总结
Prospective, monocentric study in open, aimed at evaluating the effects of supplementation with calcifediol on left ventricular function parameters in cardiopathic subjects undergoing major orthopedic surgery.
详细描述
Population of the study: 47 cardiopathic patients with hypovitaminosis D supplemented with calcifediol to reach vitamin D levels> 30 ng / ml within 6 months. The purpose of this study is to evaluate the improvement of the ejection fraction or GLS (global longitudinal strain) calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency during functional recovery after major orthopedic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: > or equal to 55 years, < or equal to 85 years
- •cardiopathic patients (including hypertension) who must undergo major orthopedic surgery at our site
- •patients with diagnosis: hypovitaminosis d
排除标准
- •presence of neoplasm
- •endocrinological pathologies excluding diabetes mellitus
- •advanced chronic renal failure (GFR < 35 ml/min)
- •pregnant women
- •impossibility to participate to the rehabilitation protocol or to perform the established controls
研究组 & 干预措施
cardiopathic patients in hypovitaminosis
Didrogyl 10 ml: 10 drops a day to obtain levels of vitamin D > 30 ng /ml. Once these values are obtained lower the dose to 4-5 drops a day, with the aim, however, of keeping the plasma values between 30 and 60 ng/ml during 6 months of the study
干预措施: Didrogyl (Drug)
结局指标
主要结局
Evaluation of improvement of ejection fraction (FE)
时间窗: 6 months
Evaluation of improvement of ejection fraction (FE) or longitudinal strain calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency who underwent supplementation with calcifediol, during functional recovery after major orthopedic surgery
次要结局
未报告次要终点