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临床试验/NCT05177081
NCT05177081Unknown不适用

Feasibility of Treatment Using Home Bioelectrical Impedance Analysis and Linked Application System in Patients With Heart Failure: A Multicenter Study

Korea University Guro Hospital4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
4
主要终点
Change from baseline in NT-proBNP

研究概览

简要总结

This study is a prospective, multi-center, open label, randomized clinical trial conducted in the republic of Korea. The objective of this study is to evaluate the efficacy and safety of the treatment using home bioelectrical impedance analysis (BIA) and linked application system in patients with heart failure (HF).

详细描述

The prevalence of HF is generally estimated at 1% to 2% of the general population. The more concerning thing is that HF patients are rapidly increasing due to an increase of elderly population derived from life extension; an increase in the number of survivors of heart disease due to the development of medical technology; and an increase in risk factors for HF such as obesity, diabetes, and ischemic heart disease.

HF is known that a quarter of HF patients are readmitted within 1 year, and the mortality rate within 5 years is about 50%. HF is a chronic condition, punctuated by acute decompensated episodes. Each acute decompensated event results in further organ damage: myocardial and renal damage occurring during such episodes may contribute to progressive left ventricular and/or renal dysfunction. Increasing frequency of acute events with disease progression leads to higher rates of hospitalization and increased risk of mortality.

The main symptoms of HF are shortness of breath and swelling, which are the main reasons for visiting the emergency room and hospitalization. After discharge, body water monitoring and management of HF patients are very important to prevent HF aggravation and re-hospitalization.

There are several methods of body fluid monitoring in HF patients. Current guidelines of heart failure recommends monitoring of pulmonary artery pressures using a wireless implantable hemodynamic monitoring system in symptomatic HF patients with previous HF hospitalization. Multi-parameter monitoring based on ICD is also recommended in order to improve clinical outcomes in HF patients. However, existing HF monitoring and management systems have limitations of its invasiveness, expensive costs and a lot of medical providers' efforts. Other body water monitoring methods are signs and symptoms monitoring and body weight-based monitoring. However, signs such as weight gain and edema or symptoms like dyspnea due to worsening heart failure were not recognized until just 7 and 3 days before the hospitalization event.

BIA, Bioelectrical impedance analysis can be a novel option for body water monitoring method in HF patients. Nowadays, it is possible to obtain more accurate body water by reflecting both intracellular and extracellular water by using multiple frequencies, and it is possible to accurately measure body water even in patients with unusual body water conditions such as heart failure status. Moreover, the changes of Bioelectrical Impedance are detected about two weeks before heart failure hospitalization. It is the key benefit for congestion monitoring and management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed heart failure
  • Patients taking loop diuretics for HF symptom control
  • Patients who can use a smart-phone

排除标准

  • Patients with implanted devices that could interfere with the BIA such as ICD and CRT
  • Patients with limb defects
  • Patients who unable to stand alone
  • Patients who are pregnant
  • Patients with End-stage renal disease (ESRD) on hemodialysis, serum creatinine of more than 5mg/dL, or nephritic syndrome
  • Patients with systemic diseases such as hypothyroidism, decompensated liver cirrhosis, and systemic lupus erythematosus.
  • Patients with active cellulitis, severe varicose vein, deep vein thrombosis or lymphedema

结局指标

主要结局

Change from baseline in NT-proBNP

时间窗: 3 months

NT-proBNP

次要结局

  • Change from baseline in Creatinine(3 months)
  • Change from baseline in edema index using BIA(3 months)
  • Change from baseline in symptom of dyspnea(3 months)
  • Rate of heart failure hospitalizations (HHF)(3 months)

研究者

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

Eung Ju Kim

Professor

Korea University Guro Hospital

研究点 (4)

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