IV Iron in Acute Decompensated Heart Failure

NCT04063033 | Completed Phase 4 FDA Drug

• 1 other identifier: 0290-19 RMB
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Functional Capacity

  The functional capacity will be evaluated by the 6 minute walk test at baseline,12 weeks and 24 weeks follow up.

  12 and 24 Weeks

Secondary Outcomes (3)

• Change in NYHA

  12 and 24 weeks

• All cause mortality

  1 Year

• Hospitalizations due to heart failure.

  1 year

Study Arms (2)

IV Iron treatment

EXPERIMENTAL

Patients will be administered IV Iron for 3-5 days. 125 mg per day.

Drug: IV iron - Sodium Ferric Gluconate Complex

No IV Iron treatment

NO INTERVENTION

Patients will receive standard treatment for heart failure without IV Iron.

Interventions

IV iron - Sodium Ferric Gluconate Complex DRUG

IV Iron will be administered 125 mg each day, to 3-5 days during hospitalisation.

Also known as: IV Ferrlecit

IV Iron treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Hb level 8-14 mg/dl on admission.
• Iron stores: Ferritin \<100 or Ferritin 100-300 and Transferrin saturation \< 20%.
• No evidence of active bleeding.
• Patient provided informed consent.

You may not qualify if:

• Cardiogenic shock or any other condition requiring IV vasopressors.
• Previous allergy or anaphylaxis due to IV Iron.
• Active malignancy undergoing treatment.
• Status post major surgery involving substantial blood loss in the past 3 months.
• Indication for Blood transfusion.
• Infection indicating IV antibiotics.
• History of acquired iron overload; known haemochromatosis or first relatives with hemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
• hemolytic anemia.
• 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.
• Recipient of immunosuppressive therapy or renal dialysis. History of erythropoietin, IV iron therapy, and blood transfusion in previous 30 days.
• 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.
• Musculoskeletal limitation that, in the judgement of the investigator, would impair cardiopulmonary exercise testing.
• Pregnant or breastfeeding.
• Inability to comprehend study protocol.
• Parallel participation in another clinical trial.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

Related Publications (1)

• Marcusohn E, Borreda I, Hellman Y, Habib M, Bahouth F, Epstein D, Zukermann R. IV Sodium Ferric Gluconate Complex in Patients With Iron Deficiency Hospitalized due to Acute Heart Failure-Investigator Initiated, Randomized Controlled Trial. J Cardiovasc Pharmacol. 2022 Aug 1;80(2):194-196. doi: 10.1097/FJC.0000000000001287.

  PMID: 35503997 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

ferric gluconate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Erez Marcusohn, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two cardiologists will examine the participants after 12 and 24 weeks and evaluate functional status and volume status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomisation to two groups, One receiving IV Iron on top of standard therapy while admitted to the hospital and the other receiving only standard therapy for acute heart failure.

Study Record Dates

• First Submitted: August 18, 2019
• First Posted: August 20, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)