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临床试验/NCT00603213
NCT00603213已完成不适用

Correlation of Intrathoracic Impedance Measure With Blood Plasma Volume in Congestive Heart Failure

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
1. correlation between change in intrathoracic impedance and change in total blood volume 2.correlation between change in intrathoracic impedance and change in plasma volume

研究概览

简要总结

Congestive heart failure is a condition in which the heart is weakened and is unable to pump enough blood to the organs of the body to meet the demands of the body. At times there may be a buildup of fluid in the lungs, legs or other parts of the body. The accumulation of this fluid has been shown to affect the resistance to flow of the electrical impulses generated in the heart. The purpose of this study is to correlate measurements to the passive flow of electricity generated by the heart within the chest (as measured by the Optivol TFS System) with measurements of the volume of blood in the body.

详细描述

Congestive heart failure (CHF) affects 5 million people in the United States, with an additional 550,000 cases diagnosed each year. Despite major recent strides in treatment, a diagnosis of CHF still carries significant annual morbidity and mortality. The resultant economic burden associated with the management of this disease has been estimated at $40 billion per year, with 60% - 75% resulting from inpatient management(1). Emergency room visits, frequent outpatient encounters and the hemodynamic monitoring and intensive care associated with inpatient management contribute significantly to this total cost.

Current outpatient heart failure management programs focus on lifestyle changes, pharmacotherapy, and disease awareness, emphasizing self identification of signs and symptoms of volume overload. Despite the best efforts of all involved, frequent unscheduled visits to the outpatient clinic or emergency department remain common, even in those patients participating in formal management programs. Accurate identification of elevated filling pressures and intravascular volume prior to the significant worsening of symptoms remains an elusive goal of management.

Although elevated jugular venous pressure and the presence of a third heart sound have been shown to have prognostic value in patients with heart failure(2), physical exam findings of elevated filling pressures do not reliably correlate with invasive hemodynamics(3).

Invasive measurement of filling pressures and cardiac output with a pulmonary artery catheter has been the gold standard for hemodynamic assessment for decades. However, this method carries significant inherent risks of placement and maintenance and is not well-suited for frequent assessment in the outpatient setting. Development of a method that would accurately and reliably identify hypervolemia and elevated filling pressures prior to the onset of symptoms may allow earlier intervention and have a significant impact on quality of life, morbidity, and mortality in patients with CHF.

Blood volume analysis has been used for over 100 years in the assessment of plasma volume and red cell mass. Earlier techniques relied on dilution of various dyes and were based on the concept that the concentration of a known quantity of dye was inversely proportional to the volume of blood into which it was injected. Later, using the same concept, 51Cr labeled red blood cells and 125I labeled albumen, were developed to measure the red cell and plasma compartments respectively. Although the dual isotope method is considered the gold standard, it is cumbersome and requires at least 6 hours for completion.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients ≥ 18 years of age with NYHA II-IV CHF of at least six months duration who have been implanted with a device capable of serial intrathoracic impedance measurement (Optivol®) will be recruited.
  • Patients implanted with an Optivol ®device will be eligible for enrollment six months following implantation
  • Women of childbearing potential may be included if they have a negative urine pregnancy test at the time of enrollment and agree to use effective contraception throughout the study and for 1 month following their participation

排除标准

  • Thoracotomy within previous 3 months
  • Chronic pericardial or pleural effusion
  • Serum albumen < 2.8 g/dL
  • Women who are pregnant or lactating
  • Inability or unwillingness to maintain adequate contraception(women of childbearing potential) for the duration of the study and for 1 month following their participation
  • Inability to give informed consent

结局指标

主要结局

1. correlation between change in intrathoracic impedance and change in total blood volume 2.correlation between change in intrathoracic impedance and change in plasma volume

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian Van Bakel

Professor of Medicine

Medical University of South Carolina

研究点 (1)

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