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

February 26, 2018 updated by: Tel-Aviv Sourasky Medical Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Department of internal medicine A

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron Carboxymaltose

standard of care + double dose of IV iron ferinject

the medicine will be given twice within one week.
Other: Standard of care
standard of care
Drug: Iron Carboxymaltose
Two IV doses
Other Names:
  • Ferinject
Other: control
standard of care
Other: Standard of care
standard of care

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Howard Oster, Dr., Physician - Internal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2016

Primary Completion (Actual)

February 6, 2018

Study Completion (Actual)

February 6, 2018

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 3, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-16-HO-512-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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