Hair Cortisol and Testosterone in Heart Failure

Systolic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139697
• Other study ID #: cortest-chf-1
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: May 15, 2012
• Start date: August 2010

Study information

• Verified date: May 2012
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure

Intervention

Other:
• Hair sampling
Hair sampling for the measurement of cortisol and testosterone

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (6)

Brotman DJ, Golden SH, Wittstein IS. The cardiovascular toll of stress. Lancet. 2007 Sep 22;370(9592):1089-100. Review. Erratum in: Lancet. 2007 Dec 1;370(9602):1828. — View Citation

Güder G, Bauersachs J, Frantz S, Weismann D, Allolio B, Ertl G, Angermann CE, Störk S. Complementary and incremental mortality risk prediction by cortisol and aldosterone in chronic heart failure. Circulation. 2007 Apr 3;115(13):1754-61. Epub 2007 Mar 19. — View Citation

Güder G, Frantz S, Bauersachs J, Allolio B, Ertl G, Angermann CE, Störk 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. — View 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. — View Citation

Sauvé 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. — View Citation

Van Uum SH, Sauvé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mortality	The association of hair cortisol and testosterone with mortality	6 and 12 months	No
Secondary	Hospital adMissions	The correlation of hair cortisol and testosterone with hospital admission	6 and 12 months	No