A Phase 4 interventional study of IV iron - Sodium Ferric Gluconate Complex in Heart Failure, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-11.
Sponsored by Rambam Health Care Campus · Phase 4, Interventional, and Treatment
The study aims Compare the effect of addition of IV FERRLECITR (ferric gluconate) to standard therapy to standard therapy alone (without any IV iron treatment) in patients admitted with acute decompensated heart failure.
Heart Failure (HF) constitutes one of the biggest burdens on the public health system, with incidence of 20 per 1000 persons above the age of 65 and up to 80 per 1000 persons above 85 years of age. Acute decompensated heart failure (ADHF) is the most common cause of hospitalizations among patients above the age of 65. Even with the advances in the treatment and management of HF, the prognosis of these patients remains poor. HF results in impaired quality of life (QoL), repeated hospitalizations and poor life expectancy.
Iron deficiency (ID) is a common comorbidity in HF patients, and is associated with poor outcome, worsening of New York Heart Association (NYHA) Class, and re-hospitalizations. While the mechanisms and pathophysiology of ID in HF is not well understood, it is presumed to be a combination of impaired absorption, renal dysfunction, hemodilution and drugs that are used for the treatment of HF.
The advantages of (intra-venous) IV ferric carboxymaltose to patients with reduced ejection fraction (HFrEF) with stable chronic heart failure and functional ID has been shown to reduce the risk of hospitalizations up to 60%, improve symptoms, exercise tolerance, functional capacity and overall QoL . Accordingly, the latest 2016 ESC Guidelines recommended the treatment in patients with HfrEF with reduced ejection fraction (HFrEF) and ID (Class IIA,LOC A).
The two major, placebo-controlled studies, mentioned above (CONFIRM-AF and FAIR-AF) have demonstrated the positive outcomes after correction of ID in stable HF patients, with a well-tolerated IV substance. However, there is no data today concerning the role of IV iron repletion in patients with decompensated HF and preserved EF. Furthermore, previous studies excluded a substantial portion of the HFrEF population recently admitted with (acute decompensated heart failure) ADHF and diagnosed with ID.
The effect of treating iron deficiency on quality of life an functional status has already been studied and found useful with various types of intravenous iron in the chronic kidney disease and inflammatory bowel disease.
In this study we aim to examine the effect of IV iron (ferric gluconate) which is a more affordable IV Iron on patients admitted due to acute heart failure with minimal exclusion criterias.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 34 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.
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Patients admitted due to acute decompensated heart failure to internal medicine department H or cardiology department.
Must meet two of the following criteria :
Exclusion Criteria:
Patients will be administered IV Iron for 3-5 days. 125 mg per day.
Drug: IV iron - Sodium Ferric Gluconate Complex
Patients will receive standard treatment for heart failure without IV Iron.
IV Iron will be administered 125 mg each day, to 3-5 days during hospitalisation.
Also known as: IV Ferrlecit
Functional Capacity
The functional capacity will be evaluated by the 6 minute walk test at baseline,12 weeks and 24 weeks follow up.
Time frame: 12 and 24 Weeks
Change in NYHA
Change in NYHA from baseline to 12 and 24 weeks
Time frame: 12 and 24 weeks
All cause mortality
Incidence of all cause mortality up to 1 year followup
Time frame: 1 Year
Hospitalizations due to heart failure.
Incidence of hospitalisations due to heart failure up to 1 year followup
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferric gluconate