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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-14

Study Completion Date

2018-02-06

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.

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iron Carboxymaltose

standard of care + double dose of IV iron ferinject

the medicine will be given twice within one week.

Group Type EXPERIMENTAL

Standard of care

Intervention Type OTHER

standard of care

Iron Carboxymaltose

Intervention Type DRUG

Two IV doses

control

standard of care

Group Type OTHER

Standard of care

Intervention Type OTHER

standard of care

Interventions

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Standard of care

standard of care

Intervention Type OTHER

Iron Carboxymaltose

Two IV doses

Intervention Type DRUG

Other Intervention Names

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Ferinject

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No