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

NCT03042130 | Withdrawn Phase 4 DMC

• 1 other identifier: TASMC-16-HO-512-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Iron Carboxymaltose

EXPERIMENTAL

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

Other: Standard of care; Drug: Iron Carboxymaltose

control

OTHER

standard of care

Other: Standard of care

Interventions

Standard of care OTHER

standard of care

Iron Carboxymaltose; control

Iron Carboxymaltose DRUG

Two IV doses

Also known as: Ferinject

Iron Carboxymaltose

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart failure grade 3-4
• Heart echo EF\< 40% (ejection fraction)
• Hb \> 10 mg/dL
• Iron\> 50 mic/dL
• Iron/ transferrin rate \> 20%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Department of internal medicine A

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care; ferric carboxymaltose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Howard Oster, Dr.

  Physician - Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: February 3, 2017
• Study Start: December 14, 2016
• Primary Completion: February 6, 2018
• Study Completion: February 6, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)