Hair Cortisol and Testosterone in Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01139697
First received: May 20, 2010
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Systolic Heart Failure
Other: Hair sampling

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hair Cortisol and Testosterone Levels and Their Correlation With Heart Failure Status in Patients With Chronic Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Correlation of hair cortisol and testosterone with heart failure status [ Time Frame: One year ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Mortality [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    The association of hair cortisol and testosterone with mortality

  • Hospital adMissions [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    The correlation of hair cortisol and testosterone with hospital admission


Biospecimen Retention:   Samples Without DNA

Hair samples for the measurment of cortisol and testosterone


Enrollment: 46
Study Start Date: August 2010
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139697

Locations
Israel
Meir Medical Center
Kfar Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: David Pereg, MD Cardiology department, Meir Medical Center
Principal Investigator: Morris Mosseri, MD Cardiology departement, Meir medical Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01139697     History of Changes
Other Study ID Numbers: cortest-chf-1
Study First Received: May 20, 2010
Last Updated: May 15, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
Heart failure
Cortisol
Testosterone

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Anti-Inflammatory Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 22, 2014