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临床试验/NCT03153774
NCT03153774Unknown不适用

Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before Transcatheter Aortic Valve Implantation

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年11月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Bioimpedance analysis data

研究概览

简要总结

The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.

The loss of muscle mass in chronic heart failure patients is a prognostic factor for sarcopenia. The purpose was to identify in these patients signs of sarcopenia for a better management.

详细描述

Age-related muscle loss, termed sarcopenia, affects 10% of elderly subjects aged 60-70 years and more than 30% above the age of 80. The concept of sarcopenia has been supported by the recent findings of muscular atrophy which was related to the decrease of protein synthesis because of the "anabolic resistance", affecting the muscular fibers type II. In fact, sarcopenia could be a consequence of chronic disease and not only an issue in the elderly people. The diagnosis is assessed by the weak muscle mass and the muscle strength and function. A description of these muscle parameters has been described in a study of 200 patients with NYHA class II-III and showed that 19,5 % have a decrease in muscle mass. They also showed that these patients have a lower functional ability. These findings prompted us to investigate the prevalence of sarcopenia in chronic heart failure subjects for a better management of these patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

Open

入排标准

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

入选标准

  • •Major patients (>18 years)
  • •Men or women
  • •Hospitalized in pre- trans aortic valvular implantation assessment in the cardiology department of the university hospital centre of Clermont-Ferrand or
  • •Patients with chronic heart failure in charge in the hospital of Clermont-Ferrand or convalescence in the pneumocardiological clinic of Durtol

排除标准

  • •Patient not affiliated to social security
  • •Inability to understand the information consent letter
  • •Not having signed informed consent
  • •Has a mental or legal incapacitation and is unable to provide informed consent.

研究组 & 干预措施

Heart failure patients

Experimental

The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.

干预措施: Assessment of sarcopenia prevalence (Diagnostic Test)

TAVI patients

Experimental

The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.

干预措施: Assessment of sarcopenia prevalence (Diagnostic Test)

结局指标

主要结局

Bioimpedance analysis data

时间窗: at day 1

Fat-free mass and body fat mass will be combined to report BMI in Kg/m2

Short physical performance battery

时间窗: at day 1

Balance test, 4-min walking test, 5 times getting-up test

Handgrip test

时间窗: at day 1

次要结局

  • Trans-thoracic echography(at day 1)
  • complete blood count CBC (white blood cells in Giga/L and red blood cells in Tera/L)(at day 1)
  • NT-ProBNP in ng/L(at day 1)
  • CRP in mg/L(at day 1)
  • Blood draw for serum creatinine in umol/L(at day 1)
  • platelets in Giga/L(at day 1)
  • urea in mmol/L(at day 1)
  • albumin in g/L(at day 1)
  • Electrocardiogram(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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