NCT01139697

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

First QC Date

May 20, 2010

Last Update Submit

May 15, 2012

Conditions

Systolic Heart Failure

Keywords

Heart failureCortisolTestosterone

Outcome Measures

Primary Outcomes (1)

  • 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: 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 Outcomes (2)

  • Mortality

    6 and 12 months

  • Hospital adMissions

    6 and 12 months

Study Arms (1)

Patients with systolic heart failure

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

Other: Hair sampling

Interventions

Hair samplingOTHER

Hair sampling for the measurement of cortisol and testosterone

Patients with systolic heart failure

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Males
  • Age \>18
  • Left ventricular (LV) systolic function (EF\<45 per echocardiography)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel, 44281, Israel

Location

Related Publications (6)

  • 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.

    PMID: 17372171BACKGROUND

  • 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.

    PMID: 17892760BACKGROUND

  • 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.

    PMID: 18609301BACKGROUND

  • 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.

    PMID: 17822755BACKGROUND

  • 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.

    PMID: 19875366BACKGROUND

  • 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.

    PMID: 19477405BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hair samples for the measurment of cortisol and testosterone

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • David Pereg, MD

    Cardiology department, Meir Medical Center

    PRINCIPAL INVESTIGATOR

  • Morris Mosseri, MD

    Cardiology departement, Meir medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2010

First Posted

June 8, 2010

Study Start

August 1, 2010

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

IL(1)