Back to resultsTreatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency
Primary Purpose
Heart Failure
Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Standard of care
Iron Carboxymaltose
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- Department of internal medicine A
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Iron Carboxymaltose
control
Arm Description
standard of care + double dose of IV iron ferinject the medicine will be given twice within one week.
standard of care
Outcomes
Primary Outcome Measures
Functioning improvement
NYHA assesment (New York Heart Association (NYHA) Functional Classification)
Quality of life improvement
KCCQ questionnaires
Functioning improvement
NYHA assesment (New York Heart Association (NYHA) Functional Classification)
Quality of life improvement
KCCQ (The Kansas City Cardiomyopathy Questionnaire)
Secondary Outcome Measures
Full Information
NCT ID
NCT03042130
First Posted
January 17, 2017
Last Updated
February 26, 2018
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03042130
Brief Title
Treatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency
Official Title
Treatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
no recruitment
Study Start Date
December 14, 2016 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
February 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iron Carboxymaltose
Arm Type
Experimental
Arm Description
standard of care + double dose of IV iron ferinject
the medicine will be given twice within one week.
Arm Title
control
Arm Type
Other
Arm Description
standard of care
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
standard of care
Intervention Type
Drug
Intervention Name(s)
Iron Carboxymaltose
Other Intervention Name(s)
Ferinject
Intervention Description
Two IV doses
Primary Outcome Measure Information:
Title
Functioning improvement
Description
NYHA assesment (New York Heart Association (NYHA) Functional Classification)
Time Frame
5 days after second administration
Title
Quality of life improvement
Description
KCCQ questionnaires
Time Frame
5 days after second administration
Title
Functioning improvement
Description
NYHA assesment (New York Heart Association (NYHA) Functional Classification)
Time Frame
1 month after second administration
Title
Quality of life improvement
Description
KCCQ (The Kansas City Cardiomyopathy Questionnaire)
Time Frame
1 month after second administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Oster, Dr.
Organizational Affiliation
Physician - Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of internal medicine A
City
Tel-Aviv
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency
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