Clinical trial NCT01139697: Hair Cortisol and Testosterone in Heart Failure
Official title: Hair Cortisol and Testosterone Levels and Their Correlation With Heart Failure Status in Patients With Chronic Congestive Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systolic Heart Failure
Keywords: Heart failure
Cortisol
Testosterone
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systolic heart failure from the out-patient clinic at the Meir Medical Center

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of hair cortisol and testosterone with heart failure status
timeFrame: One year
Secondary outcomes:
measure: Mortality
timeFrame: 6 and 12 months
measure: Hospital adMissions
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Cardiology department, Meir Medical Center
name: David Pereg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology departement, Meir medical Center
name: Morris Mosseri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guder G, Bauersachs J, Frantz S, Weismann D, Allolio B, Ertl G, Angermann CE, Stork S. Complementary and incremental mortality risk prediction by cortisol and aldosterone in chronic heart failure. Circulation. 2007 Apr 3;115(13):1754-61. doi: 10.1161/CIRCULATIONAHA.106.653964. Epub 2007 Mar 19.
citation: Sauve B, Koren G, Walsh G, Tokmakejian S, Van Uum SH. Measurement of cortisol in human hair as a biomarker of systemic exposure. Clin Invest Med. 2007;30(5):E183-91. doi: 10.25011/cim.v30i5.2894.
citation: Van Uum SH, Sauve B, Fraser LA, Morley-Forster P, Paul TL, Koren G. Elevated content of cortisol in hair of patients with severe chronic pain: a novel biomarker for stress. Stress. 2008 Nov;11(6):483-8. doi: 10.1080/10253890801887388.
citation: Brotman DJ, Golden SH, Wittstein IS. The cardiovascular toll of stress. Lancet. 2007 Sep 22;370(9592):1089-100. doi: 10.1016/S0140-6736(07)61305-1.
citation: Guder G, Frantz S, Bauersachs J, Allolio B, Ertl G, Angermann CE, Stork S. Low circulating androgens and mortality risk in heart failure. Heart. 2010 Apr;96(7):504-9. doi: 10.1136/hrt.2009.181065. Epub 2009 Oct 28.
citation: Jankowska EA, Filippatos G, Ponikowska B, Borodulin-Nadzieja L, Anker SD, Banasiak W, Poole-Wilson PA, Ponikowski P. Reduction in circulating testosterone relates to exercise capacity in men with chronic heart failure. J Card Fail. 2009 Jun;15(5):442-50. doi: 10.1016/j.cardfail.2008.12.011. Epub 2009 Feb 10.