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
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Ferritin
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Participants
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.
干预措施: Ferric carboxymaltose (Drug)
结局指标
主要结局
Ferritin
时间窗: 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%
Hemoglobin
时间窗: 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%
Transferrin saturation
时间窗: 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%
次要结局
- HF-related hospitalizations(6 and 12 months)
- EQ-5D-5L(6 and 12 months)
- Ventricular triple premature complexes during 24-hour Holter monitoring(6 and 12 months)
- Non-sustained ventricular tachycardias recorded by cardiac implantable electronic device(6 and 12 months)
- Left ventricular end-diastolic volume index (LVEDVi)(6 and 12 months)
- Left ventricular ejection fraction (LVEF)(6 and 12 months)
- Left ventricular mass index (LVMi)(6 and 12 months)
- Right ventricular fractional area change (RV FAC)(6 and 12 months)
- N-terminal prohormone of brain natriuretic peptide (NT-proBNP)(6 and 12 months)
- Appropriate therapies administered by cardiac implantable electronic device(6 and 12 months)
- Left ventricular global longitudinal strain (LV GLS)(6 and 12 months)
- 6-minute walking distance (6MWD)(6 and 12 months)
- Kansas City Cardiomyopathy Questionnaire(6 and 12 months)
- Ventricular tachycardias recorded by cardiac implantable electronic device(6 and 12 months)
- Ventricular premature complexes during 24-hour Holter monitoring(6 and 12 months)
- Peak early diastolic tissue velocity (e')(6 and 12 months)
- Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)(6 and 12 months)
- Deceleration capacity(6 and 12 months)
- Appropriate atrial mode switch events recorded by cardiac implantable electronic device(6 and 12 months)
- Non-sustained ventricular tachycardias recorded during 24-hour Holter monitoring(6 and 12 months)
- Ventricular runs recorded during 24-hour Holter monitoring(6 and 12 months)
- Ventricular dual premature complexes during 24-hour Holter monitoring(6 and 12 months)
- E-wave mitral inflow velocity (E)(6 and 12 months)
- Late potentials(6 and 12 months)
- End-tidal carbon dioxide at anaerobic threshold (etCO2-AT)(6 and 12 months)
- Heart rate turbulence (HRT)(6 and 12 months)
- Maximal oxygen consumption (VO2 max)(6 and 12 months)
- Microvolt T-wave Alternans (TWA)(6 and 12 months)