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临床试验/NCT04080388
NCT04080388Unknown3 期

How to Prevent Heart Failure Readmission by Using Lung Impedance Device (HOPE-HF Study)

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
200
试验地点
1
主要终点
Prevention of heart failure re-admission

研究概览

简要总结

The readmission of Heart Failure (HF) patients for exacerbation HF within 30-day is unmet goal. The mail reason for readmission is excessive accumulation of fluid in patient's lung. According our data (1,2) around 40% of HF patient have excessive lung fluid at discharge from HF hospitalization ("unacceptable" residual congestion on discharge). In other words, around 40% patients are discharged from HF hospitalization prematurely when they are not ready to be discharged. Only 60% of HF patients are discharged from HF admission with "acceptable" level of residual pulmonary congestion (2). There are some techniques to assess "readiness" of HF patients for discharge. Pulmonary congestion (lung fluid accumulation) may be assessed non-invasively by measurement Brain Natriuretic Peptide (BNP), (3,4), by lung ultrasound (LUS), (5-7) and by Lung Impedance (LI) method (1,2). LUS is operator depended technique. LI and BNP techniques are most reliable methods (2) and easy to use.

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
Double (Participant, Investigator)

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

  • Acute Heart Failure Patients Prior to Hospital Discharge

排除标准

  • No Cardiac Resynchronization Device Implanted During Current Hospitalization
  • Estimated glomerular filtrating rate (GFR) less than 30 ml/min

研究组 & 干预措施

Control Group

Active Comparator

Patients prior to discharge for acute heart failure admission will be examined with a lung impedance device for their suitability for discharge according to their level of pulmonary congestion. Only patients who are unsuitable for discharge according to the lung impedance assessment will be enrolled in the study. The control group (half of the patients) will be discharged without additional intervention.

干预措施: Lung Impedance Device (Diagnostic Test)

Interventional Group

Active Comparator

Patients prior to discharge for acute heart failure admission will be examined with a lung impedance device for their suitability for discharge according to their level of pulmonary congestion. Only patients who are unsuitable for discharge according to the lung impedance assessment will be enrolled in the study. The interventional group (half of the patients) will continue anti-congestive treatment while hospitalized until achieving a suitable level of decongestion.

干预措施: Lung Impedance Device (Diagnostic Test)

Interventional Group

Active Comparator

Patients prior to discharge for acute heart failure admission will be examined with a lung impedance device for their suitability for discharge according to their level of pulmonary congestion. Only patients who are unsuitable for discharge according to the lung impedance assessment will be enrolled in the study. The interventional group (half of the patients) will continue anti-congestive treatment while hospitalized until achieving a suitable level of decongestion.

干预措施: Anti-congestive treatment (Drug)

结局指标

主要结局

Prevention of heart failure re-admission

时间窗: 90 days

90-day re-admission rates will be compared between the two groups

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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