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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Standard of care
* Drug: Iron Carboxymaltose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron Carboxymaltose<br>standard of care + double dose of IV iron ferinject the medicine will be given twice within one week. | Other: Standard of care<br>* standard of care<br>Drug: Iron Carboxymaltose<br>* Two IV doses<br>* Other names: Ferinject;|
| Other: control<br>standard of care | Other: Standard of care<br>* standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functioning improvement | NYHA assesment (New York Heart Association (NYHA) Functional Classification) | 5 days after second administration | 
| Quality of life improvement | KCCQ questionnaires | 5 days after second administration | 
| Functioning improvement | NYHA assesment (New York Heart Association (NYHA) Functional Classification) | 1 month after second administration | 
| Quality of life improvement | KCCQ (The Kansas City Cardiomyopathy Questionnaire) | 1 month after second administration |