Hospitalization & Mortality in Patients With Iron Deficiency CKD and HF Treated With i.v. Iron.

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Chronic Kidney Disease
• Heart Failure
• Iron Deficiency
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT02392910
• Study type: Interventional
• Source: Hospital Aleman
• Status: Completed
• Phase: Phase 4
• Start date: March 2006
• Completion date: February 2012