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临床试验/NCT03009552
NCT03009552Unknown不适用

Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure

Marco Stephan Lofrano Alves1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
176
试验地点
1
主要终点
Composite endpoint of mortality, heart transplant, left ventricular assist device and readmission for decompensated heart failure.

研究概览

简要总结

The overall objective of the study is to determine whether speckle tracking echocardiography presents additional prognostic value to the routine assessment (clinical and echocardiographic) in patients admitted with acute decompensated heart failure (ADHF) at the emergency department. Specific objectives: 1 - To evaluate the association between changes in the cardiac contractile mechanics (by serial measurements of strain, strain rate, displacement velocity, rotation and ventricular torsion) with clinical outcomes in ADHF. 2 - Evaluate the possible association of these parameters with biomarkers of neurohormonal activity, myocardial injury, fibrosis and myocardial remodeling, inflammatory activity, and cardiorenal syndrome.

详细描述

ADHF syndromes comprise around one million of emergency admissions per year in the United States, and the number of cases tripled in the last three decades, currently representing the main cause of hospital admission in patients over the age of 65 years. A recent study showed that among patients with similar risk in the presentation of ADHF, those admitted and treated in the emergency (in attempt to get early discharge) have higher mortality rate than those treated by hospitalization. On the other hand, uncertainty about the clinical course can also result in prolonged and unnecessary hospitalizations, which burdens the health system and consumes resources. Thus, It is vital to carry out studies that bring a better understanding of the pathophysiology of ADHF and to determine new risk stratification tools in the emergency department. Echocardiography is the most widely used imaging method and has a key role in the diagnosis and management of patients with HF. However, some methodological limitations of conventional echocardiography cause low reproducibility and intra and inter-observer agreement for some parameters, reducing their prognostic ability. In recent years, new technologies have been incorporated into the method in an attempt to overcome these limitations. One of these new technologies is echocardiography with "speckle tracking". The method, by its nature, has a significant advantage over parameters derived from conventional echocardiography, because of its ultrasound beam angle-independence. However, there is a paucity of data on this new technology in patients with ADHF in literature and we have not found studies evaluating the prognostic value of this method in a prospective cohort of patients in this condition. This study aims to develop knowledge of this assessment tool for cardiac mechanics in emergency care, exploring its potential prognostic value in patients with ADHF, aiming to assist the cardiologist in identifying eligible patients for early and safe discharge, and to identify those patients for whom hospitalization and longer treatment are recommended.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission in the emergency for decompensated heart failure.

排除标准

  • Systolic blood pressure < 85, need surgical treatment, high ventricular frequency atrial fibrillation or flutter, severe pulmonary disease, pulmonary embolism, septic shock, advanced malignant neoplasia, pregnancy, heart transplant.

结局指标

主要结局

Composite endpoint of mortality, heart transplant, left ventricular assist device and readmission for decompensated heart failure.

时间窗: Six months after admission

次要结局

  • Development of cardio-renal syndrome (loss of more than 30% of calculated creatinine clearance or need for dialysis)(1 month after admission)
  • Cardiac mortality(6 months)

研究者

发起方
Marco Stephan Lofrano Alves
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marco Stephan Lofrano Alves

MD

University of Sao Paulo

研究点 (1)

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