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临床试验/NCT07138131
NCT07138131已完成不适用

Impact of Omega 3 in Treatment of Inappropriate Sinus Tachycardia

Benha University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Heart rate

研究概览

简要总结

This study aimed to evaluate the effect of omega-3 supplementation on heart rate (HR) control and heart rate variability (HRV) in children with inappropriate sinus tachycardia (IST).

详细描述

Inappropriate sinus tachycardia (IST) is a is a common disease of the autonomic nervous system in children in which tachyarrhythmia characterized by a persistent increase in resting sinus rate or disproportionate elevation of heart rate (HR) with minimal physiological effort accompanied by wide ranging symptoms including palpitations, fatigue, presyncope, and exercise intolerance it could cause lead to total disability in severe cases .it also takes a chronic course with Significant adverse effects on quality of life.

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
None

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 12 to 16 years.
  • Both sexes.
  • Patients diagnosed with inappropriate sinus tachycardia (IST).
  • Patients with resting heart rate (HR) ≥100 bpm (sitting) and/or 24-hour average HR ≥90.

排除标准

  • Structural heart disease.
  • Patients receiving antiarrhythmic medication.
  • Patients with a prior history of arrhythmias such as paroxysmal supraventricular tachycardia (PSVT) or sick sinus syndrome, or orthostatic hypotension.
  • Secondary conditions such as anemia, infection, or hyperthyroidism.

研究组 & 干预措施

Group B

Active Comparator

Patients received standard follow-up without treatment.

干预措施: Standard follow-up (Other)

Group A

Experimental

Patients received omega-3 supplementation for 3 months.

干预措施: Omega 3 (Drug)

结局指标

主要结局

Heart rate

时间窗: 24 hours post-treatment

Heart rate was recorded at baseline and post-treatment.

次要结局

  • Heart rate variability (HRV)(24 hours post-treatment)

研究者

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

Yousra Mohsen kamal Ali El -Tabakh

Assistant Lecturer of Pediatrics and Neonatology, Faculty of Medicine, Benha University, Egypt.

Benha University

研究点 (1)

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