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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03042130
Other study ID # TASMC-16-HO-512-CTIL
Secondary ID
Status Withdrawn
Phase Phase 4
First received January 17, 2017
Last updated February 26, 2018
Start date December 14, 2016
Est. completion date February 6, 2018

Study information

Verified date February 2018
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 6, 2018
Est. primary completion date February 6, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Standard of care
standard of care
Drug:
Iron Carboxymaltose
Two IV doses

Locations

Country Name City State
Israel Department of internal medicine A Tel-Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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