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临床试验/NCT02289508
NCT02289508已完成不适用

Diagnostic and Prognostic Role of USCOM in Adult Patients With Heart Failure-A Prospective Observational Study

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2014年11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
242
试验地点
1
主要终点
Difference in mean (SD) inotropy between New York Heart Association (NYHA) stages I, II, III and IV

研究概览

简要总结

Objective:

The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this study are:

  1. To investigate whether USCOM-derived haemodynamic parameters such as Cardiac output (CO), inotropy and oxygen delivery (DO2) have a role in the diagnosis of patients with a compensated heart failure syndrome (cHFS) or acute decompensated heart failure syndrome (adHFS)
  2. To investigate whether USCOM-derived haemodynamic parameters such as CO, inotropy and DO2 correlate with heart failure staging, especially New York Heart Association (NYHA) class and American Heart Association (AHA) stage.
  3. To investigate whether USCOM-derived haemodynamic parameters such as velocity time interval (vti), stroke volume (SV), CO, SV index (SVI), CO index (CI), inotropy and DO2 correlate with ejection fraction.
  4. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 30-day, 6-month and 1-year Major Adverse Cardiac Events (MACE).
  5. To evaluate the agreement between hemodynamic measurements obtained using the Ultrasonic Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography (2D-echo) measurements in groups of haemodynamically stable and unstable adult patients.

Design:

This prospective observational cohort study will be conducted in the Prince of Wales Hospital in Hong Kong.

Setting and Subjects:

Patients will be screened and recruited from adult patients either scheduled for elective 2D-echo at a cardiology clinic at the Prince of Wales Hospital, or attending the emergency department at the Prince of Wales Hospital.

Interventions:

Haemodynamic measurements made using the USCOM and 2D-echo will be compared. In order to assess inter-observer variability, a second, blinded operator will repeated 15% of scans.

详细描述

Acute heart failure syndromes (aHFS) cause almost 1 million hospitalizations annually in the United States and are the leading cause of hospitalization in persons aged over 65 years. In 2003, inpatient management of aHFS cost an estimated $12.7 billion in the United States. In 2003, 12.5% of the population in Hong Kong were aged over 65, the third highest proportion of elderly among all countries, and it is postulated that by 2033, the proportion of the elderly in the population will increase to 25%. With the growing elderly population, and the increasing prevalence of hypertension and ischemic heart disease (the major causes of heart failure), heart failure has become a major health care issue globally. In western countries the incidence ranges from 1 to 10 cases/1000/year. Other studies suggest that heart failure is a large and growing public health burden throughout Europe.

Acute exacerbation of heart failure symptoms is a common emergency department (ED) presentation and is known as acute decompensated heart failure (adHF). Acute decompensated heart failure represents the single greatest cost to the US hospitals funded by Medicaid. In Hong Kong (HK), the incidence rate of heart failure was 3-3.8/1000/year rising to 20/1000/year in women over the age of 85 years in recent years. It has been estimated that 7% of all acute medical admissions was due to this condition. In recent years there has been a 10% annual increase in admissions for patients with adHF. Currently in Hong Kong, the vast majority of ED patients with adHF are admitted as inpatients to hospital. In 2005, an audit of outcomes in patients with acute cardiogenic pulmonary oedema, the most severe manifestation of heart failure, presenting to the emergency department at the Prince of Wales Hospital showed that nearly 30% of patients die within 30 days, and a further 30% require readmission within 30 days. Recent evidence from the USA suggests that ED operated observation units are effective in managing low to medium risk adHF patients, reducing length of stay (LOS) for these patients without adversely affecting readmission rate, morbidity and mortality.

2 Dimensional echocardiography (2D-echo) is a conventional standard-of-care tool for non-invasive hemodynamic assessments in adults. In stable settings, heart failure is often characterized and classified according to ejection fraction measured by echocardiography which may be considered a pragmatic gold standard. However, the use of 2D-echo requires highly trained personnel. Obtaining measurements and calculating fundamental cardiovascular parameters such as cardiac output (CO)may take anywhere between 30 to 45 minutes, which is impractical for any setting, let alone an acute care setting. Further, such personnel are frequently not available in emergency departments. The feasibility of real time haemodynamic assessments is therefore limited with 2D-echo. More sophisticated echocardiographic techniques have been developed in an attempt to overcome the problems of sensitivity to preload and particularly afterload, but have achieved little penetration in critical care.

In acute critical care settings, the diagnosis of adHF is based on the history and clinical signs, sometimes aided by echocardiography, chest radiography and blood markers such as B-type Natriuretic Peptide (BNP). The value of BNP over clinical assessment in patients presenting with dyspnoea has been questioned and there is a need for other tools to improve diagnosis. Commencement, dosing, and withdrawal of vasopressors, vasodilators, and inotropes is still largely based on clinical assessment, sometimes assisted by measurement of surrogates of inotropy such as ejection fraction (EF) or aortic ejection velocity, despite the well-known shortcomings of these indices in critical care. This is particularly so in complex surgical patients where vascular tone and fluid loading status are highly variable and changing.

Heart failure is an abnormality of cardiac structure or function leading to failure of the heart to deliver oxygen at a rate commensurate with the requirements of the metabolizing tissues, despite normal filling pressures (or only at the expense of increased filling pressures). The commonest causes are hypertension or ischemic heart disease. If this definition holds, then heart failure should be associated with some measure of reduction in inotropy or oxygen delivery. Until recently there was no simple non-invasive, bedside test that could aid the assessment of patients with heart failure. Whilst inotropy (or myocardial contractility) as a concept is well known to all clinicians, it is seldom thought of as a measurable quantity.

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

  • Age ≥ 18 years, AND
  • Written informed consent by patient or nearest relative where appropriate, AND Either
  • Referred for echocardiography, OR
  • At least one typical symptom and one typical sign consistent with possible heart failure, OR
  • Healthy volunteers

排除标准

  • Age <18 years
  • Prior enrollment in study
  • Patients with known or suspected pregnancy

结局指标

主要结局

Difference in mean (SD) inotropy between New York Heart Association (NYHA) stages I, II, III and IV

时间窗: On Day 1

Inotropy = (Potential energy + kinetic energy) divided by BSA; measured at aortic and pulmonary window by USCOM; units W/m2

次要结局

  • Number of subjects with and without acute decompensated heart failure syndrome (adHFS)(On Day 1)
  • Difference in mean (SD) vti, FTc, SV, SVI, CO, CI, MD, SVR, SVRI, SVV, DO2, DO2I, Inotropy and ejection fraction(On Day 1)
  • Difference in mean (SD) vti, FTc, SV, SVI, CO, CI, MD, SVR, SVRI, SVV, DO2, DO2I, Inotropy and AHA stage(On Day 1)
  • Agreement between CO and SV measured separately by USCOM and 2D-Echo(On Day 1)
  • Number of subjects with and without Major Adverse Cardiac Events (MACE).(30-days, 6-months and 1-year)

研究者

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

Timothy H Rainer

Director & Professor

Chinese University of Hong Kong

研究点 (1)

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