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

Phase 4

Withdrawn

• Conditions: Heart Failure
• Interventions: Other: Standard of care; Drug: Iron Carboxymaltose

• Registration Number: NCT03042130
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-12-14
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Status Verified: 2018-02
• Primary Completion: 2018-02-06
• Study Completion: 2018-02-06
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron Carboxymaltose	Standard of care	standard of care + double dose of IV iron ferinject the medicine will be given twice within one week.
control	Standard of care	standard of care
Iron Carboxymaltose	Iron Carboxymaltose	standard of care + double dose of IV iron ferinject the medicine will be given twice within one week.

Primary Outcome Measures

Name	Time	Method
Quality of life improvement	1 month after second administration	KCCQ (The Kansas City Cardiomyopathy Questionnaire)
Functioning improvement	1 month after second administration	NYHA assesment (New York Heart Association (NYHA) Functional Classification)

Trial Locations

Locations (1)

Department of internal medicine A; 🇮🇱 Tel-Aviv, Israel