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临床试验/NCT04660396
NCT04660396已完成不适用

Monitoring Outpatient Blood VolumE in Heart Failure

Daxor Corporation1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年9月16日最近更新:
适应症

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

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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