Asess prevalence of Iron Deficiency in patients with episode of acute heart Failure at different end points
ID
Bron
Verkorte titel
Aandoening
heart failure, iron deficiency
Ondersteuning
Prof Dr Brunner
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
This study aims to analyse the prevalence of iron deficiency (ID) in patients with an episode of acute heart failure at different time points (t0 = within 24(+12h) hours of admission due to acute decompensated heart failure, t1 = after stabilisation and within 0-2 days prior to discharge, t2 = 6 weeks after discharge (+- 2 weeks, but never earlier than 4 weeks after discharge).<br>
<br>
Iron deficiency is defined as serum ferritin <100µg/l or serum ferritin =100-299µg/l and transferrin saturation <20%.
Achtergrond van het onderzoek
SUMMARY
Rationale:
The cause of iron deficiency (ID) could be gastrointestinal blood loss, poor nutrition, menstruation in fertile women, malabsorption or (chronic) inflammation, as often present in chronic disorders. Several studies showed that treatment of ID may reduce heart failure (HF)-hospitalisation, improve quality of life and alleviate heart failure (HF) symptoms of HF patients. The recently published ESC guidelines 2016 for acute and chronic heart failure recommend to consider to treat ID.
An overall prevalence of 50% has been shown in a partially Dutch cohort study in chronic HF patients. In patients with acute HF, ID may be also very common, with a prevalence of 65%. However, both prevalence percentages were not measured in real-life cohorts. Thus, it is not yet clear if there is a higher prevalence during an acute episode of heart failure as compared to chronic HF (65% vs 50%). In fact, it may be even underestimated as serum ferritin levels rise during acute inflammation as it is classified as acute phase protein, what probably masks iron deficiency. Does this give false negatives at screening for ID? Which patients are identified with ID in acute setting and are those the same patients who are identified with ID later on? What is the prevalence of real-life cohort? What are reliable time-points to measure ID in HF patients?
The expectation is that after stabilization of the HF patients, the serum ferritin values are more reliable and lab tests will show ID in >30% of all admitted patients.
Objective:
To assess the prevalence of ID in patients with an episode of acute heart failure at different time points.
Study design:
Prospective, non-interventional study assessing the prevalence of ID in a real-life cohort.
Study population:
All patients (>18yr) admitted due to an episode of acute heart failure.
Main study parameters/endpoints:
The main study parameter is the percentage of patients with ID within the total group of patients with acute heart failure and the change of ID from admission (t0) to 6 weeks after discharge (t2) via blood sample by determining Hb, TSAT and Ferritine.
t0 = within 24(+12h) hours of admission due to acute decompensated heart failure; t1 = after stabilisation and within 0-2 days prior to discharge; t2 = 6 weeks after discharge.
Doel van het onderzoek
Asess prevalence of Iron Deficiency in patients with episode of acute heart Failure at different end points
Onderzoeksopzet
t0: admission
T1: just before discharge
T2: 6 weeks after discharge
Onderzoeksproduct en/of interventie
none, observational study
Publiek
Mireille Spanjers
P debeijelaan 25
Maastricht 6229 HX
The Netherlands
003143-3877099
m.spanjers@mumc.nl
Wetenschappelijk
Mireille Spanjers
P debeijelaan 25
Maastricht 6229 HX
The Netherlands
003143-3877099
m.spanjers@mumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age> 18 years
Admission with an episode of acute heart failure
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- History of erythropoietin stimulating agent, IV iron therapy, and/or blood transfusion within 3 months prior to hospitalisation.
- Oral iron therapy at any doses in 4 weeks prior to hospitalization or iron containing multivitamins irrespectively of the dose of iron.
- History of receiving systemic chemotherapy and/or radiotherapy in 3 months prior to hospitalisation.
Opzet
Deelname
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