Hair Cortisol and Testosterone in Heart Failure

NCT ID: NCT01139697

Last Updated: 2012-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

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

Conditions

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Systolic Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with systolic heart failure

Patients with systolic heart failure defined as ejection fraction \<45%

Hair sampling

Intervention Type OTHER

Hair sampling for the measurement of cortisol and testosterone

Interventions

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Hair sampling

Hair sampling for the measurement of cortisol and testosterone

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Pereg, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology department, Meir Medical Center

Morris Mosseri, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology departement, Meir medical Center

Locations

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Meir Medical Center

Kfar Saba, Israel, Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 17372171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17892760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18609301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17822755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19875366 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19477405 (View on PubMed)

Other Identifiers

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cortest-chf-1

Identifier Type: -

Identifier Source: org_study_id

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