EUCTR2018-001488-21-ES进行中(未招募)1 期
EFFECT OF VITAMIN D SUPPLEMENTATION ON THE VENTRICULAR DEFORMATION RATE (STRAIN RATE) IN PATIENTS WITH HEART FAILURE WITH PRESERVED OR MODERATELY REDUCED EYECTION FRACTIO
Sergio Aleman0 个研究点目标入组 102 人开始时间: 2018年7月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A.- Heart failure with preserved or moderately reduced ejection fraction (HFp / HFmr) that meet diagnostic criteria according to the Clinical Guidelines of the European Society of Cardiology :
- •- At least one episode of symptoms and / or signs of heart failure in the last 6 months.
- •- Demonstrated ejection fraction> 40% (including clinical entities of preserved and moderately reduced ejection fraction).
- •- Elevation natriuretic peptides: NTproBNP> 125 pg / ml or
- •BNP> 35 pg / ml
- •- Demonstration of structural heart disease: Left ventricular hypertrophy / left atrial enlargement / diastolic dysfunction
- •B.- Vitamin D deficiency demonstrated with serum levels <20 ng / mL (vitamin deficit).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 102
排除标准
- •- Active treatment with Vitamin D supplements.
- •- Advanced chronic kidney disease with glomerular filtration <30 ml / min / 1.73m2.
- •- Malabsorptive syndromes that interfere with the absorption of vitamin D.
- •- Diseases that affect the metabolism of calcium and phosphorus.
- •- Hypercalcemia (serum calcium corrected with albumin> 10.5 mg / dL).
- •- Severe valvular disease of any origin.
- •- Atrial fibrillation.
- •- Severe psychosocial problems (dementia, alcoholism, any consumption of toxics, psychiatric disorders or moderate or severe cognitive impairment of any origin that prevent the patient's follow-up or adherence to the study).
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