Hair Cortisol and Testosterone in Heart Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01139697|
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : May 16, 2012
|Condition or disease||Intervention/treatment|
|Systolic Heart Failure||Other: Hair sampling|
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
|Study Type :||Observational|
|Actual Enrollment :||46 participants|
|Official Title:||Hair Cortisol and Testosterone Levels and Their Correlation With Heart Failure Status in Patients With Chronic Congestive Heart Failure|
|Study Start Date :||August 2010|
Patients with systolic heart failure
Patients with systolic heart failure defined as ejection fraction <45%
Other: Hair sampling
Hair sampling for the measurement of cortisol and testosterone
- Correlation of hair cortisol and testosterone with heart failure status [ Time Frame: One year ]
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
- Mortality [ Time Frame: 6 and 12 months ]The association of hair cortisol and testosterone with mortality
- Hospital adMissions [ Time Frame: 6 and 12 months ]The correlation of hair cortisol and testosterone with hospital admission
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139697
|Meir Medical Center|
|Kfar Saba, Israel, 44281|
|Principal Investigator:||David Pereg, MD||Cardiology department, Meir Medical Center|
|Principal Investigator:||Morris Mosseri, MD||Cardiology departement, Meir medical Center|