Iron Intravenous Therapy in Reducing the Burden of Severe Arrhythmias in Heart Failure With Reduced Ejection Fraction

NCT04974021 | Unknown FDA Drug

• 1 other identifier: 219/12-3-19
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

An open label,single-center, non-interventional prospective study with the aim on investigating the effect of intravenous ferric carboxymaltose in restoring iron status and reducing the risk of severe arrhythmic events in participants with iron deficiency and a reduced ejection fraction (HFrEF).

Conditions

Ferric Carboxymaltose; Heart Failure With Reduced Ejection Fraction; Arrhythmias, Cardiac

Keywords

ferric carboxymaltose; heart failure; arrhythmias

Outcome Measures

Primary Outcomes (3)

• Hemoglobin

  Measured in g/dL, will be aggregated to form a composite primary endpoint of hemoglobin ≥ 12g/dL, plasma ferritin ≥ 50 ng/mL and transferrin saturation \> 20%

  6 and 12 months

• Ferritin

  Measured in ng/mL, will be aggregated to form a composite primary endpoint of hemoglobin ≥ 12g/dL, plasma ferritin ≥ 50 ng/mL and transferrin saturation \> 20%

  6 and 12 months

• Transferrin saturation

  Measured as a percentage, will be aggregated to form a composite primary endpoint of hemoglobin ≥ 12g/dL, plasma ferritin ≥ 50 ng/mL and transferrin saturation \> 20%

  6 and 12 months

Secondary Outcomes (28)

• HF-related hospitalizations

  6 and 12 months

• N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

  6 and 12 months

• Kansas City Cardiomyopathy Questionnaire

  6 and 12 months

• EQ-5D-5L

  6 and 12 months

• Ventricular tachycardias recorded by cardiac implantable electronic device

  6 and 12 months

Study Arms (1)

Participants

HFrEF patients undergoing iron therapy with intravenous carboxymaltose (FCM). FCM administered dosage as per clinical routine. FCM administration is repeated no sooner than 3 months than last therapy, based on repeat ferritin and transferrin saturation levels.

Drug: Ferric carboxymaltose

Interventions

Ferric carboxymaltose DRUG

Intravenous ferric carboxymaltose for the treatment of iron deficiency in HFrEF as per 2016 European Society of Cardiology Heart Failure guidelines.

Also known as: Ferinject

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with heart failure and reduced ejection fraction, cardiac implantable electronic devices and iron deficiency visiting the outpatient HF clinic of the Third Department of Cardiology AUTh

You may qualify if:

• Diagnosis of HFrEF (LVEF≤40%)
• Implanted cardiac implantable electronic device with at least 3 months of recorded arrhythmic history
• Patient is scheduled to receive IV ferric carboxymaltose to treat diagnosed iron deficiency

You may not qualify if:

• Myocardial infarction, acute heart failure or life-threatening arrhythmias in the preceding 15 days
• Autoimmune disorders, cancer or other diseases other than heart failure that significantly affect patients' life expectancy, appetite and emotional status
• Known allergic reaction to ferric carboxymaltose.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Hippokration General Hospital of Thessaloniki, Third Department of Cardiology (Aristotle University of Thessaloniki)

Thessaloniki, Macedonia, GR54642, Greece

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Failure

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vassilios P Vassilikos, PhD

  Hippokration General Hospital of Thessaloniki, Third Department of Cardiology, AUThi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 23, 2021
• Study Start: June 20, 2019
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

GR (1)