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

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title: An Open Label,Single-center, Non-interventional Prospective Study to Determine the Efficacy of Iron Therapy Using Intravenous Ferric Carboxymaltose and Its Effect in Reducing Arrhythmic Events in Participants With Iron Deficiency and HFrEF

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04974021
• Study type: Observational
• Source: Aristotle University Of Thessaloniki
• Status: Active, not recruiting
• Start date: June 20, 2019
• Completion date: September 30, 2021