Hair Cortisol and Testosterone in Heart Failure
Information source: Meir Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systolic Heart Failure
Intervention: Hair sampling (Other)
Phase: N/A
Status: Completed
Sponsored by: Meir Medical Center Official(s) and/or principal investigator(s): David Pereg, MD, Principal Investigator, Affiliation: Cardiology department, Meir Medical Center Morris Mosseri, MD, Principal Investigator, Affiliation: Cardiology departement, Meir medical Center
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.
Clinical Details
Official title: Hair Cortisol and Testosterone Levels and Their Correlation With Heart Failure Status in Patients With Chronic Congestive Heart Failure
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Correlation of hair cortisol and testosterone with heart failure status
Secondary outcome: MortalityHospital adMissions
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Meir Medical Center, Kfar Saba 44281, Israel
Additional Information
Related publications: 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. 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. 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. 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. 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. 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.
Starting date: August 2010
Last updated: May 15, 2012
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