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Hepcidin in Anemic Chronic Heart Failure (CHF) Patients

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ClinicalTrials.gov Identifier: NCT00437866
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Background: Anemia in chronic heart failure (CHF) is directly linked to increased mortality and reduced exercise capacity. The pathomechanism for the development of anemia in CHF is not well understood. Impairment of iron homeostasis is discussed to be one of the major triggers in anemia of chronic disease. Hepcidin was recently described as the central regulator of iron homeostasis.

Main hypothesis: Plasma hepcidin levels are altered in anemic CHF patients compared to non anemic controls and might be a main contributing factor of anemia in CHF.

Iron regulator-hypothesis High levels of cytokines in CHF patients cause up-regulation of hepcidin, which in turn leads to low iron uptake causing anemia. In this case venous hepcidin and hemoglobin concentrations should both correlate with cytokine levels.

Erythropoietin regulator-hypothesis Dysregulation of the erythropoietin system results in anemia, which represses hepcidin. This leads to a negative correlation between hemoglobin and hepcidin in plasma.

Methods: 100 consecutive patients diagnosed with systolic CHF will be prospectively included in the study. Iron status will be assessed and hepcidin, erythropoietin as well as interleukin-1, interleukin-6 and soluble TNF alpha receptor levels will be measured by ELISA.

Patients will be followed up for one year and mortality, rehospitalization and worsening of CHF will be documented.


Condition or disease
Anemia Chronic Heart Failure

Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hepcidin in the Pathogenesis of Anemia in Patients With Chronic Heart Failure
Study Start Date : January 2007
Primary Completion Date : February 2008
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Hemodilution

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Heart failure outpatients
Criteria

Inclusion Criteria:

  1. Systolic left ventricular dysfunction (LVEF<45%)
  2. Signed informed consent

Exclusion Criteria:

  1. Women of child bearing potential
  2. Pregnancy
  3. Non cardiac illness limiting life expectancy to <1 year
  4. Renal disease of non-cardiac reason
  5. Malignancy
  6. Chronic inflammatory disease
  7. Acute infection
  8. Erythropoietin therapy or iron substitution within the last 6 months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437866


Locations
Austria
Medical University of Vienna
Vienna, Vienna-Austria, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Martin Huelsmann, MD Medical University of Vienna
More Information

Publications:
Responsible Party: Martin Huelsmann, PI, Doctor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00437866     History of Changes
Other Study ID Numbers: Version 1.0, 25.11.2006
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Heart Failure
Anemia
Heart Diseases
Cardiovascular Diseases
Hematologic Diseases
Hepcidins
Anti-Infective Agents