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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03042130
Enrollment
0
Registered
2017-02-03
Start date
2016-12-14
Completion date
2018-02-06
Last updated
2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

OTHERStandard of care

standard of care

DRUGIron Carboxymaltose

Two IV doses

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functioning improvement5 days after second administrationNYHA assesment (New York Heart Association (NYHA) Functional Classification)
Quality of life improvement5 days after second administrationKCCQ questionnaires

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026