Systolic Heart FailureNCT01139697
Hair Cortisol and Testosterone in Heart Failure
An observational study of Systolic Heart Failure, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Systolic Heart Failure
- What is being tested?
- Hair sampling
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systolic heart failure from the out-patient clinic at the Meir Medical Center
Who may be able to join
- Males
- Age >18
- Left ventricular (LV) systolic function (EF<45 per echocardiography)
Who cannot join
- 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
Show all 10Show fewer
- Inability to provide 3 cm hair sample from vertex posterior.
- Dyed hair
- Morbid obesity (BMI>35)
- Any symptomatic chronic lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Systolic Heart Failure
- Being tested
- Hair sampling
- Keywords
- Heart failure, Cortisol, Testosterone
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair samplingOther
Hair sampling for the measurement of cortisol and testosterone
| Study group | Role | What they receive |
|---|---|---|
| Patients with systolic heart failure | Patients with systolic heart failure defined as ejection fraction <45% Receives: Other: Hair sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Ejection fraction as assessed by echo-doppler.
- Physical capacity as assessed by stress test.
- Serum levels of hs-CRP, NT-proBNP. 4)1 year mortality
5)hospital admissions after 6 and 12 months
Measured: One year
Secondary outcomes (2)
Mortality
The association of hair cortisol and testosterone with mortality
Measured: 6 and 12 months
Hospital adMissions
The correlation of hair cortisol and testosterone with hospital admission
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Pereg, MD, Principal investigator, Cardiology department, Meir Medical CenterMorris Mosseri, MD, Principal investigator, Cardiology departement, Meir medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139697
- Sponsor's protocol ID
- cortest-chf-1
- Status last verified
- May 2012
- First submitted
- 20 May 2010
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17372171Sauve 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.
PubMed 17892760Van 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.
PubMed 18609301Brotman 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.
PubMed 17822755Guder 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.
PubMed 19875366Jankowska 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.
PubMed 19477405
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Cortisol and Testosterone Levels and Their Correlation With Heart Failure Status in Patients With Chronic Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT01139697
- Acronym / sponsor ID
- cortest-chf-1
- Conditions
- Systolic Heart Failure
- Keywords
- Heart failure, Cortisol, Testosterone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- First posted
- 8 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with systolic heart failure | – | Other: Hair samplingPatients with systolic heart failure defined as ejection fraction <45% |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systolic heart failure from the out-patient clinic at the Meir Medical Center
Key inclusion criteria (3 listed)
- Males
- Age >18
- Left ventricular (LV) systolic function (EF<45 per echocardiography)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hair samplingHair sampling for the measurement of cortisol and testosterone | Other | Patients with systolic heart failure |
Primary outcome
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
2 secondary outcomes
Mortality
Time frame: 6 and 12 months
Hospital adMissions
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
- Background: PubMed 17372171Guder 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.
- Background: PubMed 17892760Sauve 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.
- Background: PubMed 18609301Van 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.
- Background: PubMed 17822755Brotman 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.
- Background: PubMed 19875366Guder 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.
- Background: PubMed 19477405Jankowska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pereg, MD principal investigator
Cardiology department, Meir Medical Center
Morris Mosseri, MD principal investigator
Cardiology departement, Meir medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systolic Heart Failure, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of hair cortisol and testosterone with heart failure status (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01139697, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012; AzTrials last refreshed its copy on 6 Nov 2026.