Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Heart Failure Event within 90 days post discharge
研究概览
简要总结
The goal of this clinical trial is to test whether using Bioimpedance Analysis (BIA) can help manage fluid levels in patients with heart failure who are admitted to the hospital with worsening symptoms. The main questions it aims to answer are:
1. Does BIA-guided fluid management reduce the need for extra treatment (in the form of diuretics which helps remove excess fluid from the body) or re-hospitalization for heart failure within 90 days after discharge?
Researchers will compare a group receiving BIA-guided treatment to a standard care group to see if BIA provides better results in managing fluid levels.
Participants will be randomly assigned to one of two groups:
BIA-Guided Treatment Group: Have BIA measurements done within 24 hours of admission and throughout their hospital stay to guide diuretic treatment.
Standard Care Group: Have BIA measurements taken at admission and discharge, but the results will not be shared with the clinical team, who will manage fluid levels as usual.
All patients will attend a follow-up visit in 2-4 weeks after discharge where the patient will undergo standard health checks, blood tests, and a questionnaire about how heart failure affects their quality of life.
The investigators will then compare both groups for the primary outcome measure, which is the rates of rehospitalisation or need for additional decongestive treatment, within 90 days of discharge from hospital.
详细描述
SCIENTIFIC RATIONALE Heart failure (HF) is a global health challenge affecting over 64 million people, with rising prevalence. Managing HF effectively is crucial to improving outcomes, but assessing and managing fluid status remains a significant challenge. Fluid congestion is a common cause of symptoms and hospitalizations for acute decompensated heart failure (ADHF). National audits indicate many patients are discharged before achieving adequate decongestion, increasing the risk of readmission and worsening prognosis.
Traditional methods, such as physical exams and imaging, correlate poorly with congestion. Conditions like obesity (BMI >30) and kidney disease further reduce the accuracy of diagnostic tools, including echocardiography and biomarkers like NT-proBNP. Hospitalizations for decompensated HF are associated with worse prognosis, progressive cardiac dysfunction, and higher mortality, highlighting the need for improved in-hospital management and prevention of readmissions.
Bioimpedance Analysis (BIA) is a promising non-invasive tool that measures body composition and fluid distribution, providing insights into total, intra-, and extracellular water. BIA is inexpensive, portable, and reproducible, making it suitable for regular clinical use. Studies suggest BIA-guided therapy may improve fluid management and reduce NT-proBNP levels, potentially enhancing outcomes.
This study aims to evaluate BIA's effectiveness in guiding fluid management in hospitalized HF patients with worsening symptoms. By enabling precise fluid assessment, BIA could optimize diuretic therapy and improve patient outcomes.
PRIMARY RESEARCH OBJECTIVE The principal research objective is to determine if BIA guided management of heart failure inpatients, compared to usual standard of care, results in a reduction in heart failure events within 90 days post discharge.
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
- 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
- 否
入选标准
- •Age >18 years
- •Patients with hospitalised with a decompensated episode of Heart Failure regardless of Ejection Fraction
- •Able and willing to consent.
排除标准
- •Patients on a palliative care pathway and/or estimated life expectancy <3 months
- •Patients admitted to ITU/ on intensive care support.
- •Patients currently taking part in any trials investigating new heart failure drug or interventional treatment.
- •Patients requiring Renal Replacement Therapy.
- •Patients unable or unwilling to give consent.
结局指标
主要结局
Heart Failure Event within 90 days post discharge
时间窗: 90 days post discharge
This is defined as outpatient requirement to increase oral diuretics or hospitalization for intravenous diuretics due to decompensated heart failure.
次要结局
- Evidence of Acute Kidney Injury(At any time from hospitalisation till follow-up in Outpatient clinic 2-4 weeks after discharge)
- Hospital Length of stay(30 days)
- NT pro-BNP after discharge from hospital(2-4 weeks after discharge from hospital)
- Patient Reported outcomes after discharge from hospital(2-4 weeks post discharge)
- All-cause Hospitalisation at 3months(90 days)
- All-cause Hospitalisation at 6 months(6 months)
- All-cause hospitalisation at 12 months(12 months)
- All-cause mortality at 12 months(12 months)