Hair Cortisol and Testosterone in Heart Failure

May 15, 2012 updated by: Meir Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel, 44281
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with systolic heart failure from the out-patient clinic at the Meir Medical Center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Ejection fraction as assessed by echo-doppler.
  2. Physical capacity as assessed by stress test.
  3. Serum levels of hs-CRP, NT-proBNP. 4)1 year mortality

5)hospital admissions after 6 and 12 months
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 6 and 12 months
The association of hair cortisol and testosterone with mortality
6 and 12 months
Hospital adMissions
Time Frame: 6 and 12 months
The correlation of hair cortisol and testosterone with hospital admission
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: David Pereg, MD, Cardiology department, Meir Medical Center
  • Principal Investigator: Morris Mosseri, MD, Cardiology departement, Meir medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (ESTIMATE)

June 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cortest-chf-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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