NCT04013373终止不适用
Home-Based Fluid Status Monitoring in Heart Failure Patients Recently Hospitalized for Acute Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 92
- 试验地点
- 15
- 主要终点
- Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water
研究概览
简要总结
This is a prospective, multi-center, single-arm study enrolling adult patients who have been hospitalized for heart failure and subsequently discharged. For the duration of study participation, patients will obtain daily at-home bioimpedance measurements. Heart failure symptoms, medications, and re-hospitalizations will be tracked. Additionally, quality of life questionnaires will be administered at the beginning and end of study participation.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or older
- •NYHA Class II or III at the time of study enrollment
- •Undergoing discharge following hospitalization for acute heart failure
- •Planned continued treatment for heart failure
- •Patient is able to stand or sit upright for bioimpedance spectroscopy measurements
- •Patient reports access to reliable Wi-Fi connection at home
- •Patient reports adequate space for the SOZO device at home
- •Patient provides written informed consent and authorization to use and disclose health information, including willingness to comply with study procedures
排除标准
- •Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator)
- •Patient has a confirmed diagnosis of acute coronary syndrome during current admission
- •Patient is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion
- •Patient has a clinical condition that would not allow them to complete the study
- •Patient has had surgical revascularization using saphenous vein grafting that may affect venous return
- •Patient is pregnant or lactating
- •Patient has nephrotic syndrome or nephrosis
- •Patient has end-stage renal disease requiring chronic dialysis
- •Patient has been diagnosed with lymphedema
- •Patient has chronic liver failure or cirrhosis
- •Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days
- •Patient has an amputation of a limb [Exception: amputation of digits may not affect bioimpedance spectroscopy measurements and will be permitted at the discretion of the study sponsor]
- •Patient has any other medical condition that, in the opinion of the investigator, will impair the subject's ability to complete study procedures or participate in the protocol
结局指标
主要结局
Serial bioimpedance spectroscopy (BIS) measurements including extracellular fluid and total body water
时间窗: 45 days
Characterize BIS trends that precede hospital readmissions for heart failure
次要结局
未报告次要终点
研究者
研究点 (15)
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