No registrations found.
ID
Source
Brief title
Health condition
heart failure, iron deficiency
Sponsors and support
Prof Dr Brunner
Intervention
Outcome measures
Primary outcome
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).
Iron deficiency is defined as serum ferritin <100µg/l or serum ferritin =100-299µg/l and transferrin saturation <20%.
Secondary outcome
To determine at what time point screening for ID is reliable after a patient is hospitalized due to an acute episode (guidance for cardiologists).
To analyse the prevalence of ID in subgroups (female, LVEF, NYHA, co-morbidities (hypertension, diabetes mellitus, COPD/asthma, CVA/TIA, cancer, anaemia, systemic inflammatory disorders, valve disease, atrial fibrillation), eGFR and CRP and anemia).
For possible later analyses, left-over of already drawn serum may be stored (at discretion of the investigators, until further notice in MUMC Maastricht, Zuyderland Hospital Heerlen and Amphia hospital Breda only). Such analyses might include measurement of hepcidine or soluble transferrin-receptor, among other biomarkers, to better define the role of iron deficiency in the acute setting of HF. This may also give insight if measurements of ferritin provide reliable results or if definition of ID should be different in the acute setting.
Background summary
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.
Study objective
Asess prevalence of Iron Deficiency in patients with episode of acute heart Failure at different end points
Study design
t0: admission
T1: just before discharge
T2: 6 weeks after discharge
Intervention
none, observational study
Mireille Spanjers
P debeijelaan 25
Maastricht 6229 HX
The Netherlands
003143-3877099
m.spanjers@mumc.nl
Mireille Spanjers
P debeijelaan 25
Maastricht 6229 HX
The Netherlands
003143-3877099
m.spanjers@mumc.nl
Inclusion criteria
Age> 18 years
Admission with an episode of acute heart failure
Exclusion criteria
- 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6868 |
| NTR-old | NTR7046 |
| CCMO | NL59894.096.16 |
| OMON | NL-OMON50256 |