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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Aleman
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion:

• LV ejection fraction (EF) ≤ 35%

• New York Heart Association (NYHA) functional class II to IV

• Anemia with an iron deficit defined by Hb 12.5 g/dl for men and 11.5 g/dl for women, and some of the following: serum ferritin 100 ng/ml and/or with transferrin saturation (TSAT) 20%

• Creatinine clearance 90 ml/min.

Exclusion:

• Hemodialysis therapy

• Anemia not due to iron deficiency

• NYHA functional class I

• History of allergy to the iron supplements

• Acute bacterial infections, parasitism known in the 4 previous weeks

• Neoplasm

• Chronic digestive diseases

• Hypothyroidism

• Congenital cardiopathies

• Receiving iron supplements in the 4 previous weeks

• Receiving rhEPO in the 4 previous weeks

• History of hospitalization during the 4 weeks before enrollment into the study.