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临床试验/NCT02728739
NCT02728739已完成不适用

Incidence of Significant Mitral Regurgitation in Patients Presenting With Acute Heart Failure: Journey to Tertiary Centre

Metanoic Health Ltd.2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
2
主要终点
Grade 3 and above mitral regurgitation in acute heart failure.

研究概览

简要总结

The purpose of this study is to determine the prevalence of moderate-to-severe Mitral Regurgitation (MR) in acute Heart Failure (HF) patients requiring hospital admission.

详细描述

All patients admitted with symptoms of HF- (shortness of breath (SOB), peripheral oedema, palpitations and irregular heart beats) will be assessed by the Research Team. The level of BNP will be checked using a small device (i-STAT BNP) at the bedside. If results of the test suggest HF they will undergo special procedure called transthoracic echocardiography (TTE). TTE is an ultrasound scan of the heart which will enable the investigators' to grade severity of Mitral Regurgitation (MR) as well as strength of the heart muscle. The investigators will use bi-plane Simpton's method to calculate left ventricular (LV) ejection fraction (EF). Colour Doppler and PISA method will be used to quantify severity of MR or valve leak. Simultaneously there will be recording of heart sounds to find out if auscultation is reliable in identifying leaky valves.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute Heart Failure patients admitted to the Hospital
  • Elevated BNP level (>30pg/ml)

排除标准

  • Patients with BNP level (< 30pg/ml)

结局指标

主要结局

Grade 3 and above mitral regurgitation in acute heart failure.

时间窗: 12 months

TTE Grading is done on colour Doppler and proximal isovelocity surface area (PISA) method.

次要结局

  • Establish correlation between BNP level and severity of MR in acute HF(12 months)
  • The validity of Hospital Episode Statistics (HES) data against prevalence of grade 3-4 MR in the study.(12 month)

研究者

发起方
Metanoic Health Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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