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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03042130
• Other study ID #: TASMC-16-HO-512-CTIL
• Status: Withdrawn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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Heart Failure

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