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临床试验/EUCTR2018-001488-21-ES
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).

研究者

发起方
Sergio Aleman

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