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临床试验/NCT01139697
NCT01139697已完成不适用

Hair Cortisol and Testosterone Levels and Their Correlation With Heart Failure Status in Patients With Chronic Congestive Heart Failure

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2010年8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
46
试验地点
1
主要终点
Correlation of hair cortisol and testosterone with heart failure status

研究概览

简要总结

The purpose of this study is to determine whether hair cortisol and testosterone levels correlate with heart failure status in patient with chronic congestive heart failure.

详细描述

Progression of chronic congestive heart failure (CHF) is associated with abnormal secretion of several hormones including glucocorticoids and testosterone.

A single study of patients with chronic heart failure has demonstrated that higher serum levels of cortisol are independent predictors of increased mortality risk. However, this study included patients with heart failure who were admitted to the hospital due to other causes and it might be speculated that the single serum cortisol measurement taken may have been influenced by the acute illness or by the emotional stress associated with the admission itself.

Currently, there are several modalities for measuring cortisol levels including serum, urinary and salivary techniques. However, all these methods represent indicators of acute cortisol secretion and do not reflect accumulation of the hormone over time. Recently there has been a growing interest in measuring hair cortisol level. Hair grows approximately 1 centimeter per month and therefore hair analysis accurately reflects long-term endogenous production of cortisol. This provides for the first time a reliable mode for the measurement of the accumulation of cortisol over time. We have recently demonstrated higher hair cortisol levels in patients with acute myocardial infarction compared with controls (the manuscript has been submitted for publication). Regarding testosterone, several studies have recently demonstrated lower free serum testosterone levels in patients with heart failure compared with controls. Furthermore, Serum testosterone levels were inversely correlated with heart failure status.

The longitudinal assessment of cortisol and testosterone levels over time using the hair technique may be superior to a single random serum sample for the assessment of chronic heart failure status and prognosis.

If indeed, hair cortisol and testosterone levels would correlate with heart failure status, they may be used as a quantitative mode for clinical follow-up of CHF patients (similar to the role of HbA1C in the follow-up of diabetic patients). However this hypothesis has not yet been evaluated

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
Male
接受健康志愿者

入选标准

  • Left ventricular (LV) systolic function (EF<45 per echocardiography)

排除标准

  • Any corticosteroid treatment in the last 6 months
  • Any treatment with testosterone in the last 6 months
  • Diagnosis or Cushing's or Addison's disease
  • Any hospital admission within 3 months prior to enrollment
  • Inability to sign inform consent
  • Patients with moderate or severe aortic stenosis
  • Inability to provide 3 cm hair sample from vertex posterior.
  • Dyed hair
  • Morbid obesity (BMI>35)
  • Any symptomatic chronic lung disease

结局指标

主要结局

Correlation of hair cortisol and testosterone with heart failure status

时间窗: One year

Ccorrelation of hair cortisol and testosterone with clinical and laboratory parameters that their correlation with heart failure status is well established including: 1. Ejection fraction as assessed by echo-doppler. 2. Physical capacity as assessed by stress test. 3. Serum levels of hs-CRP, NT-proBNP. 4)1 year mortality 5)hospital admissions after 6 and 12 months

次要结局

  • Mortality(6 and 12 months)
  • Hospital adMissions(6 and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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