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临床试验/NCT02959372
NCT02959372已完成不适用

Lung Ultrasoung Guided Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2016年11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
发起方
入组人数
124
试验地点
2
主要终点
mortality or re-hospitalization

研究概览

简要总结

Introduction: Despite the great advances in treatment, heart failure (HF) continues to be an important health problem because of its high prevalence, morbidity, mortality and associated costs. Research shows at least 40% of HF in-patients are going to be readmitted in the following year. Thus, new strategies to reduce HF decompensations are needed.

In recent studies, pulmonary congestion which is expressed in the form of B-lines detected by lung ultrasound (LUS) has proven to be a potent prognostic predictor of hospitalization and mortality in HF. Moreover, the use of LUS is becoming more common due to its availability (with pocket devices with sizes approaching those of smart phones); its simplicity (rapid learning curve and rapid examination, less than 5 minutes) and its safety (radiation free).

We hypothesize that a management guided by LUS in HF patients may improve outcomes.

Objective: The aim of our study is to evaluate if ambulatory LUS guided treatment of patients after a hospitalization for HF, decreases the combined end-point of mortality or re-hospitalization after a 6 months follow-up.

Study design: The design of our study is a randomized, simple blinded, clinical trial.

Eligible patients are patients older than 18 years of age who have been hospitalized for HF. The exclusion criteria are life expectancy of less than 6 months or uninterpretable lung ultrasound. Eligible patients are going to be randomized into either the "LUS group" or the "control group".

The follow-up consists of visits to the HF clinic at periods of 15 days, 1, 3 and 6 months after the initial hospitalization. LUS is going to be performed on all patients despite their respective group. Only in relation to the "LUS group", the treating physician will have the result of the examination and the subsequent treatment adjustment could be made in response to those findings.

This study complies with the Declaration of Helsinki and the study protocol is being evaluated by the Ethic Committee of our institution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

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

  • Age over 18 years old
  • Current hospitalization for heart failure decompensation

排除标准

  • Not able to do the follow up
  • Life expectancy of less than 6 months
  • uninterpretable lung ultrasound

研究组 & 干预措施

lung ultrasound group

Experimental

lung ultrasound results

干预措施: lung ultrasound (Other)

control group

Placebo Comparator

The attending physician will not have the result of the lung ultrasound

干预措施: placebo (Other)

结局指标

主要结局

mortality or re-hospitalization

时间窗: 6 months follow-up

次要结局

未报告次要终点

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
责任方
Sponsor

研究点 (2)

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