IV Iron in Acute Decompensated Heart Failure

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Drug: IV iron - Sodium Ferric Gluconate Complex

• Registration Number: NCT04063033
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-08-18
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Study Start: 2019-09-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Patients admitted due to acute decompensated heart failure to internal medicine department H or cardiology department.

   • Must meet two of the following criteria :

     • NT pro BNP > 300 pg/ml (>800 pg/ml in the presence of Atrial Fibrillation).
     • Peripheral pitting edema,
     • Jugular Venous Distention,
     • pulmonary edema/congestion according to physical examination or Chest X-ray.

   • IV furosemide treatment on admission to ER or internal ward/cardiology department.

2. Hb level 8-14 mg/dl on admission.

3. Iron stores: Ferritin <100 or Ferritin 100-300 and Transferrin saturation < 20%.

4. No evidence of active bleeding.

5. Patient provided informed consent.

Exclusion Criteria

1. Cardiogenic shock or any other condition requiring IV vasopressors.
2. Previous allergy or anaphylaxis due to IV Iron.
3. Active malignancy undergoing treatment.
4. Status post major surgery involving substantial blood loss in the past 3 months.
5. Indication for Blood transfusion.
6. Infection indicating IV antibiotics.
7. History of acquired iron overload; known haemochromatosis or first relatives with hemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
8. hemolytic anemia.
9. History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the upper limit of the normal range; chronic lung disease; myelodysplastic disorder; and known HIV/AIDS disease.
10. Recipient of immunosuppressive therapy or renal dialysis. History of erythropoietin, IV iron therapy, and blood transfusion in previous 30 days.
11. Unstable angina pectoris, as judged by the investigator; severe uncorrected valvular disease or left ventricular outflow obstruction; obstructive cardiomyopathy; uncontrolled fast atrial fibrillation or flutter (heart rate >110 beats per minute [bpm]); uncontrolled symptomatic brady- or tachyarrhythmias.
12. Musculoskeletal limitation that, in the judgement of the investigator, would impair cardiopulmonary exercise testing.
13. Pregnant or breastfeeding.
14. Inability to comprehend study protocol.
15. Parallel participation in another clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Iron treatment	IV iron - Sodium Ferric Gluconate Complex	Patients will be administered IV Iron for 3-5 days. 125 mg per day.

Primary Outcome Measures

Name	Time	Method
Functional Capacity	12 and 24 Weeks	The functional capacity will be evaluated by the 6 minute walk test at baseline,12 weeks and 24 weeks follow up.

Secondary Outcome Measures

Name	Time	Method
Change in NYHA	12 and 24 weeks	Change in NYHA from baseline to 12 and 24 weeks
All cause mortality	1 Year	Incidence of all cause mortality up to 1 year followup
Hospitalizations due to heart failure.	1 year	Incidence of hospitalisations due to heart failure up to 1 year followup

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel