Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437866
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2007-02-20
Brief Title:
Hepcidin in Anemic Chronic Heart Failure CHF Patients
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Hepcidin in the Pathogenesis of Anemia in Patients With Chronic Heart Failure
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None