Hepcidin in Anemic Chronic Heart Failure (CHF) Patients
NCT ID: NCT00437866
Last Updated: 2012-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2007-01-31
2010-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent
Exclusion Criteria
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
18 Years
ALL
Yes
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Martin Huelsmann
PI, Doctor
Principal Investigators
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Martin Huelsmann, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University of Vienna
Vienna, Vienna-Austria, Austria
Countries
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References
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Adlbrecht C, Kommata S, Hulsmann M, Szekeres T, Bieglmayer C, Strunk G, Karanikas G, Berger R, Mortl D, Kletter K, Maurer G, Lang IM, Pacher R. Chronic heart failure leads to an expanded plasma volume and pseudoanaemia, but does not lead to a reduction in the body's red cell volume. Eur Heart J. 2008 Oct;29(19):2343-50. doi: 10.1093/eurheartj/ehn359. Epub 2008 Aug 12.
Other Identifiers
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Version 1.0, 25.11.2006
Identifier Type: -
Identifier Source: org_study_id