Arrhythmias, Cardiac, Ferric Carboxymaltose, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
ferric carboxymaltose, heart failure, arrhythmias
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.
Interventions
DRUGFerric carboxymaltose
Intravenous ferric carboxymaltose for the treatment of iron deficiency in HFrEF as per 2016 European Society of Cardiology Heart Failure guidelines.
Sponsors
Aristotle University Of Thessaloniki
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 6 and 12 months | 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% |
| Ferritin | 6 and 12 months | 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% |
| Transferrin saturation | 6 and 12 months | 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L | 6 and 12 months | 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%. |
| Ventricular tachycardias recorded by cardiac implantable electronic device | 6 and 12 months | Compared with 12 months preceding recruitment. |
| Non-sustained ventricular tachycardias recorded by cardiac implantable electronic device | 6 and 12 months | Compared with 12 months preceding recruitment. |
| Appropriate therapies administered by cardiac implantable electronic device | 6 and 12 months | Compared with 12 months preceding recruitment. |
| Appropriate atrial mode switch events recorded by cardiac implantable electronic device | 6 and 12 months | Compared with 12 months preceding recruitment. |
| Non-sustained ventricular tachycardias recorded during 24-hour Holter monitoring | 6 and 12 months | Compared with baseline. |
| Ventricular runs recorded during 24-hour Holter monitoring | 6 and 12 months | Compared with baseline. |
| Ventricular triple premature complexes during 24-hour Holter monitoring | 6 and 12 months | Compared with baseline. |
| Ventricular dual premature complexes during 24-hour Holter monitoring | 6 and 12 months | Compared with baseline. |
| Ventricular premature complexes during 24-hour Holter monitoring | 6 and 12 months | Compared with baseline. |
| Left ventricular end-diastolic volume index (LVEDVi) | 6 and 12 months | Compared to baseline. Measured in mL/m\^2. |
| Left ventricular ejection fraction (LVEF) | 6 and 12 months | Compared to baseline. Measured as a percentage. |
| HF-related hospitalizations | 6 and 12 months | Hospitalizations due to acute-on-chronic heart failure or worsening heart failure (compared with 12 months preceding treatment) |
| Left ventricular global longitudinal strain (LV GLS) | 6 and 12 months | Compared to baseline. Measured as a percentage. |
| Peak early diastolic tissue velocity (e') | 6 and 12 months | Μeasured at the septal and lateral mitral annulus. Used to calculate E/e' ratio. Measured as m/s. |
| E-wave mitral inflow velocity (E) | 6 and 12 months | Used to calculate E/e' ratio. Measured as m/s. |
| Right ventricular fractional area change (RV FAC) | 6 and 12 months | Compared to baseline. Measured as a percentage. |
| 6-minute walking distance (6MWD) | 6 and 12 months | Distance recorded during six-minute walk testing. Measured in meters. Compared to baseline. |
| Maximal oxygen consumption (VO2 max) | 6 and 12 months | Maximal oxygen consumption recorded during cardiopulmonary exercise testing. Measured in mL/kg/min. Compared to baseline. |
| Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) | 6 and 12 months | The VE/VCO2 slope recorded during cardiopulmonary exercise testing. Absolute unit. Compared to baseline. |
| End-tidal carbon dioxide at anaerobic threshold (etCO2-AT) | 6 and 12 months | Recorded during cardiopulmonary exercise testing. Measured in mmHg. Compared to baseline. |
| Late potentials | 6 and 12 months | Signal Averaged ECG (SAECG) enables the detection of late potentials. Specialist software automatically performs the detection of late potentials in patients' Holter monitor recordings. |
| Microvolt T-wave Alternans (TWA) | 6 and 12 months | Specialist software quantifies microvolt TWA voltage in patients' Holter monitor recordings. microvolt TWA is measured in μV. |
| Heart rate turbulence (HRT) | 6 and 12 months | 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. |
| Deceleration capacity | 6 and 12 months | (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). |
| Left ventricular mass index (LVMi) | 6 and 12 months | Compared to baseline. Measured in g/m\^2. |
| N-terminal prohormone of brain natriuretic peptide (NT-proBNP) | 6 and 12 months | NT-proBNP levels measured in serum (compared to baseline). NT-proBNP values are reported in pg/mL. |
| Kansas City Cardiomyopathy Questionnaire | 6 and 12 months | 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) |
Countries
Greece
Outcome results
None listed