Hepcidin in Anemic Chronic Heart Failure (CHF) Patients

Anemia Clinical Trial

Official title:

Hepcidin in the Pathogenesis of Anemia in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437866
• Other study ID #: Version 1.0, 25.11.2006
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: December 5, 2012
• Start date: January 2007
• Est. completion date: July 2010

Study information

• Verified date: December 2012
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EC of the Medical University of Vienna
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Chronic Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna	Vienna-Austria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Adlbrecht C, Kommata S, Hülsmann M, Szekeres T, Bieglmayer C, Strunk G, Karanikas G, Berger R, Mörtl 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodilution			No