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

Aristotle University Of Thessaloniki106 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

106

Conditions

Ferric Carboxymaltose Heart Failure With Reduced Ejection Fraction Arrhythmias, Cardiac

Interventions

Ferric carboxymaltoseDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Thessaloniki, Macedonia, Greece

Outcomes

Primary Outcomes

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%

Time frame: 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%

Time frame: 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%

Time frame: 6 and 12 months

Secondary Outcomes

HF-related hospitalizations

Hospitalizations due to acute-on-chronic heart failure or worsening heart failure (compared with 12 months preceding treatment)

Time frame: 6 and 12 months

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

NT-proBNP levels measured in serum (compared to baseline). NT-proBNP values are reported in pg/mL.

Time frame: 6 and 12 months

Kansas City Cardiomyopathy Questionnaire

HF-specific QoL quantified with the Kansas City Cardiomyopathy Questionnaire (compared to baseline). The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status. The questionnaire ranges from 0% (worst possible QoL) to 100% (best possible QoL)

Time frame: 6 and 12 months

Data from ClinicalTrials.gov

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General QoL is quantified with the EQ-5D-5L questionnaire (compared to baseline). EQ-5D-5L is a standardised measure of health-related quality of life. It contains a short descriptive system questionnaire and a visual analogue scale (EQ VAS). VAS ranges 0% to 100%.

Time frame: 6 and 12 months

Ventricular tachycardias recorded by cardiac implantable electronic device

Compared with 12 months preceding recruitment.

Time frame: 6 and 12 months

Non-sustained ventricular tachycardias recorded by cardiac implantable electronic device

Compared with 12 months preceding recruitment.

Time frame: 6 and 12 months

Appropriate therapies administered by cardiac implantable electronic device

Compared with 12 months preceding recruitment.

Time frame: 6 and 12 months

Appropriate atrial mode switch events recorded by cardiac implantable electronic device

Compared with 12 months preceding recruitment.

Time frame: 6 and 12 months

Non-sustained ventricular tachycardias recorded during 24-hour Holter monitoring

Compared with baseline.

Time frame: 6 and 12 months

Ventricular runs recorded during 24-hour Holter monitoring

Compared with baseline.

Time frame: 6 and 12 months

Ventricular triple premature complexes during 24-hour Holter monitoring

Compared with baseline.

Time frame: 6 and 12 months

Ventricular dual premature complexes during 24-hour Holter monitoring

Compared with baseline.

Time frame: 6 and 12 months

Ventricular premature complexes during 24-hour Holter monitoring

Compared with baseline.

Time frame: 6 and 12 months

Left ventricular end-diastolic volume index (LVEDVi)

Compared to baseline. Measured in mL/m\^2.

Time frame: 6 and 12 months

Left ventricular ejection fraction (LVEF)

Compared to baseline. Measured as a percentage.

Time frame: 6 and 12 months

Left ventricular mass index (LVMi)

Compared to baseline. Measured in g/m\^2.

Time frame: 6 and 12 months

Left ventricular global longitudinal strain (LV GLS)

Compared to baseline. Measured as a percentage.

Time frame: 6 and 12 months

Peak early diastolic tissue velocity (e')

Μeasured at the septal and lateral mitral annulus. Used to calculate E/e' ratio. Measured as m/s.

Time frame: 6 and 12 months

E-wave mitral inflow velocity (E)

Used to calculate E/e' ratio. Measured as m/s.

Time frame: 6 and 12 months

Right ventricular fractional area change (RV FAC)

Compared to baseline. Measured as a percentage.

Time frame: 6 and 12 months

6-minute walking distance (6MWD)

Distance recorded during six-minute walk testing. Measured in meters. Compared to baseline.

Time frame: 6 and 12 months

Maximal oxygen consumption (VO2 max)

Maximal oxygen consumption recorded during cardiopulmonary exercise testing. Measured in mL/kg/min. Compared to baseline.

Time frame: 6 and 12 months

Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)

The VE/VCO2 slope recorded during cardiopulmonary exercise testing. Absolute unit. Compared to baseline.

Time frame: 6 and 12 months

End-tidal carbon dioxide at anaerobic threshold (etCO2-AT)

Recorded during cardiopulmonary exercise testing. Measured in mmHg. Compared to baseline.

Time frame: 6 and 12 months

Late potentials

Signal Averaged ECG (SAECG) enables the detection of late potentials. Specialist software automatically performs the detection of late potentials in patients' Holter monitor recordings.

Time frame: 6 and 12 months

Microvolt T-wave Alternans (TWA)

Specialist software quantifies microvolt TWA voltage in patients' Holter monitor recordings. microvolt TWA is measured in μV.

Time frame: 6 and 12 months

Heart rate turbulence (HRT)

Heart rate turbulence (HRT) is the baroreflex-mediated short-term oscillation of cardiac cycle lengths after spontaneous ventricular premature complexes. Specialist software detects abnormal HRT in patients' Holter monitor recordings. The existence of abnormal heart rate turbulence is a nominal variable.

Time frame: 6 and 12 months

Deceleration capacity

(Heart rate) deceleration capacity is a measurement of autonomic nerve regulation in heart failure. Specialist software quantifies deceleration capacity, which is measured in milliseconds (ms).

Time frame: 6 and 12 months