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临床试验/NCT04860921
NCT04860921Unknown不适用

Oral Zinc Supplementation in Children With Dilated Cardiomyopathy : Aprospective Cohort Study in Assiut ,Egypt.

Assiut University0 个研究点目标入组 50 人开始时间: 2021年4月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
New york heart associaton functional classification for grading heart failure

研究概览

简要总结

The aim of this study is to detect effect of oral zinc supplementation in pediatric patients with dilated cardiomyopathy.

详细描述

Cardiomyopathies are group of heart diseases that influence cardiac muscles directly and are not related to hypertension, congenital, valvular and pericardial diseases. The most common type of cardiomyopathy is dilate cardiomyopathy.

Dilated cardiomyopathy usually manifests as chronic systolic heart failure leading to arrhythmias and sudden death.

Trace elements are known to have a key role in myocardial metabolism. The human heart requires energy from micro and macro nutrients both to regenerate proteins and cells, and to support cyclic contractions. Heart failure is associated with neuro-hormonal activation leading to elevated levels of inflammatory markers and oxidative stress.

Zinc is an essential micronutrient that impacts the cardiovascular system. There are multiple potential pathophysiologic causes for zinc deficiency in heart failure as result of impaired micronutrient consumption, hyper inflammatory state, diminished absorption and hyperzincuria from heart failure medications. Zinc deficiency may play a role as primary and possible reversible cause of dilated cardiomyopathy.

Plasma zinc levels have been reported in multiple observational studies of patients with heart failure particularly in studies of idiopathic dilated cardiomyopathy, serum zinc levels have been found to be low.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children (1-18) year's age with impaired left ventricular systolic function due to dilated cardiomyopathy

排除标准

  • patients with congenital heart diseases.
  • patients less than one year age.

结局指标

主要结局

New york heart associaton functional classification for grading heart failure

时间窗: 1.5 year

All cases included the study will be carefully examined for sings of heart failure according to new york heart association classification for grading of heart failure

次要结局

  • Detailed echocardiographic examination(1.5 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Safaa Abdel Hameed Ahmed

Principal investigator

Assiut University

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