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

Tel Aviv Sourasky Medical Center

Status and phase: Withdrawn; Phase 4

Conditions: Heart Failure

Treatments: Other: Standard of care; Drug: Iron Carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT03042130

TASMC-16-HO-512-CTIL

Details and patient eligibility

About

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.

Full description

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. The parameters that will be measured will include clinical, lab, echo, and quality of life questionnaires.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Iron Carboxymaltose

Experimental group

Description:

standard of care + double dose of IV iron ferinject the medicine will be given twice within one week.

Treatment:

Drug: Iron Carboxymaltose

Other: Standard of care

control

Other group

Description:

standard of care

Treatment:

Other: Standard of care