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

Aristotle University Of Thessaloniki

Status: Unknown

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

Treatments: Drug: Ferric carboxymaltose

Study type: Observational

Funder types: Other

Identifiers

NCT04974021

219/12-3-19

Details and patient eligibility

About

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).

Full description

Patients with HFrEF already scheduled to receive IV FCM to treat iron deficiency will be included in this registry trial. These patients undergo clinical examination, echocardiography, blood testing, 6-minute walking testing, cardiopulmonary exercise testing, cardiac implantable device interrogation, 24-hour Holter monitoring and quality of life quantification as part of standard clinical practice. This database will be extracted from clinical databases and stored on a separate, registry database. The study will examine the effect of IV FCM on patients' iron stores, arrhythmic burden, hospitalizations and clinical, echocardiographic, exercise-testing-derived and biological markers of disease severity such as 6-minute walking distance, peak VO2 consumption, LVEF and LV global longitudinal strain and NT-proBNP.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

106 participants in 1 patient group

Participants

Description:

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.

Treatment:

Drug: Ferric carboxymaltose