Treatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency

• Status: Withdrawn
• Trial end date: 2018-02-06
• Target enrollment: 0
• Participant gender: All

Summary

Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The control group will receive standard of care alone. The study will test for the effects of the additional IV iron on the symptoms, clinical picture and quality of life of the treated patients.

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

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Treatments: Ferric Compounds; Iron

Criteria

Inclusion Criteria:

• Heart failure grade 3-4

• Heart echo EF< 40% (ejection fraction)

• Hb > 10 mg/dL

• Iron> 50 mic/dL

• Iron/ transferrin rate > 20%

Exclusion Criteria:

• Infection

• Acute ischemia

• Patients that didn't receive the standard of care during 3 days before investigational product administration

• Hemochromatosis

• Known allergy to one of the products of the investigational product.

• Macrocytic anemia

• Iron excess

• Pregnant women

• Mentally disabled patients which can't give their concent properly.