Heart Failure Clinical Trial
Official title:
Hospitalization and Mortality in Iron Deficient, Anemic Patients With Chronic Kidney (CKD) and Heart Failure Receiving Intravenous Iron Therapy: A Five Year Follow-up From a Pilot Study
Iron deficiency, independent of anemia, appears to increase morbidity and mortality as well as impairing health-related quality of life in chronic heart failure (CHF), and these effects are compounded when patients also experience chronic kidney disease (CKD). This study was designed to determine the effects of intravenous iron treatment on morbidity and mortality following an initial 6-month period and a longer period of up to 5 years.
Effect of i.v. iron sucrose on iron parameters and anemia
- During the original 6 month trial, patients in the i.v. iron group received 1000mg iron
per the protocol. No patients required iron in the subsequent 6 months.
- During the subsequent follow-up, patients required a mean of between 165 and 274 mg
iron per year (range: 0 to 600 mg per patient per year).
- Post the initial 1000mg iron, 19 out of 20 patients required at least a second dose of
i.v. iron. Most patients required only one or two doses per year.
- The average time to requiring a second iron administration was 14.5 ± 2.7 months
(range: 14 months, 23 months).
- Correction of iron deficiency (ID) resulted in statistically significant increases in
transferrin saturation (TSAT) throughout the study (p < 0.01 untreated group). At all
measured points, TSAT values in the treated group were at least on target (> 20%
increase).
- For serum ferritin, significant differences were observed at 6 months and 1 year
however this difference was not observed at 5 years post baseline where serum ferritin
values were 173ng/mL and 167ng/mL for the control and IV iron groups, respectively.
- Statistically significant improvements versus the untreated group were observed for
both hemoglobin (Hb) and creatinine clearance (CrCl) as well as for left ventricular
ejection fraction (LVEF) and New York Heart Association (NYHA) functional class at each
year.
Effect of i.v. iron sucrose on hospitalizations and mortality
- There were numerically fewer hospitalization reported at 6 months compared to those
among untreated patients (0% and 25%, respectively), although the difference versus
untreated patients was not statistically significant (p=ns).
- At 1 year after commencing the original study, the number of patients requiring a
hospitalization (for any reason) was 50% in the control group and 10% in the IV iron
group (p<0.01).
- By 5 years follow-up these rates had increased to 85% in the control arm and 20% in the
IV iron treated group (p<0.01).
- In relation to all-cause mortality, there were no deaths in either group after the
first 6 months. The number of deaths due to any cause after year 1 had increased in
both groups (20% in the untreated group, 5% in the treated group; p=ns).
- At 5 years follow-up, 11 (55%) of patients in the control arm were deceased, compared
with 4 (20%) in the IV iron treated group (p < 0.05).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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