Clinical trial NCT04974021: Iron Intravenous Therapy in Reducing the Burden of Severe Arrhythmias in Heart Failure With Reduced Ejection Fraction
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ferric Carboxymaltose
Heart Failure With Reduced Ejection Fraction
Arrhythmias, Cardiac
Keywords: ferric carboxymaltose
heart failure
arrhythmias
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin
timeFrame: 6 and 12 months
measure: Ferritin
timeFrame: 6 and 12 months
measure: Transferrin saturation
timeFrame: 6 and 12 months
Secondary outcomes:
measure: HF-related hospitalizations
timeFrame: 6 and 12 months
measure: N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
timeFrame: 6 and 12 months
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: 6 and 12 months
measure: EQ-5D-5L
timeFrame: 6 and 12 months
measure: Ventricular tachycardias recorded by cardiac implantable electronic device
timeFrame: 6 and 12 months
measure: Non-sustained ventricular tachycardias recorded by cardiac implantable electronic device
timeFrame: 6 and 12 months
measure: Appropriate therapies administered by cardiac implantable electronic device
timeFrame: 6 and 12 months
measure: Appropriate atrial mode switch events recorded by cardiac implantable electronic device
timeFrame: 6 and 12 months
measure: Non-sustained ventricular tachycardias recorded during 24-hour Holter monitoring
timeFrame: 6 and 12 months
measure: Ventricular runs recorded during 24-hour Holter monitoring
timeFrame: 6 and 12 months
measure: Ventricular triple premature complexes during 24-hour Holter monitoring
timeFrame: 6 and 12 months
measure: Ventricular dual premature complexes during 24-hour Holter monitoring
timeFrame: 6 and 12 months
measure: Ventricular premature complexes during 24-hour Holter monitoring
timeFrame: 6 and 12 months
measure: Left ventricular end-diastolic volume index (LVEDVi)
timeFrame: 6 and 12 months
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 6 and 12 months
measure: Left ventricular mass index (LVMi)
timeFrame: 6 and 12 months
measure: Left ventricular global longitudinal strain (LV GLS)
timeFrame: 6 and 12 months
measure: Peak early diastolic tissue velocity (e')
timeFrame: 6 and 12 months
measure: E-wave mitral inflow velocity (E)
timeFrame: 6 and 12 months
measure: Right ventricular fractional area change (RV FAC)
timeFrame: 6 and 12 months
measure: 6-minute walking distance (6MWD)
timeFrame: 6 and 12 months
measure: Maximal oxygen consumption (VO2 max)
timeFrame: 6 and 12 months
measure: Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)
timeFrame: 6 and 12 months
measure: End-tidal carbon dioxide at anaerobic threshold (etCO2-AT)
timeFrame: 6 and 12 months
measure: Late potentials
timeFrame: 6 and 12 months
measure: Microvolt T-wave Alternans (TWA)
timeFrame: 6 and 12 months
measure: Heart rate turbulence (HRT)
timeFrame: 6 and 12 months
measure: Deceleration capacity
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Hippokration General Hospital of Thessaloniki, Third Department of Cardiology (Aristotle University of Thessaloniki)
state: Macedonia
Study officials:
affiliation: Hippokration General Hospital of Thessaloniki, Third Department of Cardiology, AUThi
name: Vassilios P Vassilikos, PhD
role: PRINCIPAL_INVESTIGATOR
References: