Not provided
Not provided
Not provided
Not provided
Not provided
no recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron Carboxymaltose | Experimental | standard of care + double dose of IV iron ferinject the medicine will be given twice within one week. |
|
| control | Other | standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | standard of care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Howard Oster, Dr. | Physician - Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of internal medicine A | Tel Aviv | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| C522335 | ferric carboxymaltose |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Iron Carboxymaltose |
| Drug |
Two IV doses |
|
|