Monitoring Outpatient Blood VolumE in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Quantify volume shifts in post discharge heart failure patients
研究概览
简要总结
In patients discharged following heart failure treatment, the consistency of blood volume status and components over time is unknown. The primary objective is to describe the rate of change, if any, of the plasma volume and red blood cell volume following hospitalization and discharge of patients with heart failure.
详细描述
Over 6 million Americans suffer from heart failure, one of the most prevalent and deadly diseases. High 30-day readmission and mortality rates have persisted despite advances in care. Clinical guidelines suggest blood volume assessment and clinical management to euvolemia or normal blood volume, but standard methods of blood volume diagnosis have been shown to be unreliable. FDA-cleared Blood volume analysis (BVA) has been used to quantify otherwise undiagnosed blood volume derangements in heart failure and other indications. Also, care guided by BVA has been demonstrated to improve inpatient heart failure readmission and mortality. A similar analysis has not previously been performed immediately following hospital discharge, though this period is understood to be challenging due to high variability of patient status, physiology, and compliance.
This is a prospective, single-center, observational open-label study. The primary objective is to quantify changes to plasma volume and red blood cell volume over a 12 week period post-discharge.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized male and female patients with primary or secondary admission diagnosis of acute heart failure exacerbation
- •> 18 years of age
- •Able and willing to provide consent
- •Reduced or preserved LVEF
排除标准
- •Diagnosed with current acute strokes
- •Pregnant women
- •Severe hypotension requiring resuscitation, intubation or circulatory support
- •Cardiogenic shock
- •Patients with known cardiac amyloid and hypotension
- •Known allergy to iodine or iodinated albumin
结局指标
主要结局
Quantify volume shifts in post discharge heart failure patients
时间窗: 12 weeks
Accurately quantify changes to plasma volume and red blood cell volume in HF outpatients over the 12-week period following discharge.
次要结局
未报告次要终点
