Fluid Guided Heart Failure Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Congestion Index Alert Statistics
研究概览
简要总结
FIGHT-HF is an exploratory non-randomized open-label study evaluating a heart failure management intervention.
The goal of this pilot is to assess the performance of a fluid-guided heart failure management program and Alert Response Guide (ARG) using the Bodyport Cardiac Scale and Congestion Index in 50 adult participants with acute and chronic heart failure, who are followed by a Cleveland Clinic cardiologist.
详细描述
This study will assess the clinical integration of the Cardiac Scale and a composite biomarker algorithm, the Congestion Index and Alert, into existing health system workflows for HF management. The data collected in this study will be used to test and refine existing Congestion Index-guided HF management protocols contained within an Alert Response Guide (ARG). The final Alert Response Guide may be further validated in future randomized control trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized for acute decompensated heart failure
- •Age 21 years or older
- •Able to speak and read English
排除标准
- •New York Heart Association functional class IV symptoms
- •Received or are scheduled to receive a heart transplant or ventricular assist - device in the next 12 months
- •Have a glomerular filtration rate of less than 25 mL/min while nonresponsive to diuretic therapy or on chronic renal dialysis
- •Have a history of regularly scheduled intravenous HF therapy (e.g., inotropes or diuretics)
- •Have a life expectancy of less than 12 months
- •Are pregnant or plan to become pregnant during the next 12 months
- •Weigh greater than 375 lbs
- •Unable to stand on two bare feet without assistance
结局指标
主要结局
Congestion Index Alert Statistics
时间窗: From enrollment to the end of the study duration at 90 days
Congestion Index Alert Statistics
时间窗: From enrollment to the end of the study duration at 90 days
次要结局
未报告次要终点