Hair Cortisol and Testosterone in Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Systolic Heart Failure

Intervention / Treatment
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* Other: Hair sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males Age >18 Left ventricular (LV) systolic function (EF<45 per echocardiography) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with systolic heart failure<br>Patients with systolic heart failure defined as ejection fraction <45% | Other: Hair sampling<br>* Hair sampling for the measurement of cortisol and testosterone<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | The association of hair cortisol and testosterone with mortality | 6 and 12 months | 
| Hospital adMissions | The correlation of hair cortisol and testosterone with hospital admission | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Cortisol, Testosterone