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临床试验/NCT00843245
NCT00843245Unknown不适用

Study of Electrical Bioimpedance in Heart Failure Patients Followed at the Heart Failure Unit of the Santa Creu i Sant Pau Hospital.

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
1
主要终点
To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure.

研究概览

简要总结

The purpose of this study is to determine how electrical impedance is modified in relation to extracellular space body fluid retention detected by an electrical bioimpedance method in patients with heart failure.

详细描述

Heart failure (HF) is a clinical syndrome presenting currently a high prevalence, morbidity and mortality. The lack of sensitivity of symptoms and signs used to make the diagnosis of the exacerbation of HF, and the knowledge in recent years about the relevance to detect congestion before consulting a specialist or go to the emergency department, support the need of more aggressive management of these patients.

Bioimpedance monitoring devices for bioimpedance can provide useful data for the detection of congestion onset and help the decision-making in treatment.

Because patients with heart failure suffer alterations in body composition, mainly due to the amount of extracellular water, the bioimpedance can objectify these variations. In heart failure, bioimpedance has been tested in two studies with small samples of patients estimating total body water. In other studies , the monitoring of intrathoracic impedance has been performed by measurement systems implanted in cardiac defibrillators or in cardiac resynchronization devices. They have proven to be useful for early detection of decompensation in these patients and to detect changes in impedance before the patient begins the clinical manifestations. Furthermore, it has been correlated the detection of decompensation by these devices with significant increases in NT- proBNP (diagnostic and prognostic marker for HF).

The purpose of our study is to observe these changes in impedance from the patient's skin surface and non-invasively.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Outpatients > 18 years of age, male or female

排除标准

  • Patients treated with renal substitutive treatment such as hemodialysis or peritoneal dialysis
  • Patients with automatic implantable devices or pacemakers.
  • Patients with metal prosthesis in right side of the body

结局指标

主要结局

To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure.

时间窗: 18 months

次要结局

  • To analyze segmental and whole-body bioimpedance measures in a population of heart failure patients with multi frequency body composition analysis(18 months)
  • To study the relation between electrical bioimpedance changes with patients' clinical situation (compensated versus decompensated HF)(18 months)
  • To assess potential correlations between impedance, clinical status, heart failure functional class, and NT-proBNP.(18 months)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other

研究点 (1)

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Study of Electrical Bioimpedance in Heart Failure. | 临床试验