Impact of Iron Deficiency With and Without Anemia on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Incidence of anemia and iron deficiency in hospitalized patients with HF
研究概览
简要总结
The relationship between iron deficiency (with or without anemia) and arrhythmic risk or ECG abnormalities in hospitalized HF patients remains poorly characterized. This is particularly relevant in settings where advanced iron therapies (e.g., intravenous iron supplementation) may not be readily available, and where simple clinical and electrocardiographic markers could help identify high-risk patients by evaluating the impact of iron deficiency (with and without anemia) arrhythmic events and resting ECG changes among patients admitted with heart failure. Understanding these associations may offer insights into the arrhythmogenic potential of iron deficiency and support the integration of iron status assessment into routine risk stratification and management of HF patients.
详细描述
Heart failure (HF) is a major global health problem, associated with high morbidity, mortality, and frequent hospitalizations. Beyond impaired cardiac function, HF is recognized as a systemic syndrome involving a wide range of metabolic, inflammatory, and hematologic disturbances that contribute to disease progression and adverse outcomes. Iron deficiency has emerged as a prevalent and clinically relevant comorbidity, affecting up to 55% of chronic HF patients and in up to 80% of those with AHF, even in the absence of overt anemia.
Iron plays a central role in cellular energy metabolism, oxidative phosphorylation, and mitochondrial function, processes that are especially critical in the metabolically demanding environment of the myocardium.
In patients with HF, anemia and iron deficiency has been associated with reduced exercise capacity, impaired quality of life, and increased risk of hospitalization, cardiovascular and all-cause mortality. While the impact of iron deficiency on functional status and survival has been widely investigated, its potential influence on cardiac electrical activity remains less well studied.
Emerging evidence suggests that iron deficiency may contribute to electrophysiological instability by promoting oxidative stress, altering repolarization, and impairing myocardial conduction. This could create a potential substrate for arrhythmias, which are a major cause of morbidity in patients with HF. Moreover, subtle resting electrocardiographic (ECG) abnormalities, such as QT prolongation, T-wave changes, or conduction delays, may reflect early electrical remodeling in the context of iron deficiency-even in the absence of clinically apparent arrhythmias
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
- •Adult patients (≥18 years) admitted to Assiut University Heart Hospital with a clinical diagnosis of heart failure (new-onset or decompensated).
- •Includes all ejection fraction categories (HFrEF, HFmrEF, and HFpEF).
- •Availability of 12-lead ECG, serum iron studies (ferritin, transferrin saturation, serum iron), and routine laboratory tests.
- •Willingness to participate and provide informed consent.
排除标准
- •Known history of primary electrical disorders (e.g., Brugada syndrome, Long QT syndrome, etc.).
- •Recent intravenous iron therapy or blood transfusion within the past 3 months.
- •End-stage renal disease requiring dialysis.
- •Known anemia due to non-iron-deficiency causes (e.g., hemolytic anemia, active malignancy, etc.).
- •Severe electrolyte imbalances (e.g., significant hypo-/hyperkalemia, hypo-/hypermagnesemia).
- •Active systemic infection, chronic inflammatory conditions, or recent chemotherapy.
- •severe valvular lesions
结局指标
主要结局
Incidence of anemia and iron deficiency in hospitalized patients with HF
时间窗: through study completion, an average of 1 year
The proportion of patients admitted with heart failure who are found to have anemia and/or iron deficiency during hospitalization. Anemia is defined according to WHO criteria (Hb \<13 g/dL in men, \<12 g/dL in women). Iron deficiency is defined as ferritin \<100 ng/mL, or ferritin 100-299 ng/mL with transferrin saturation \<20%.
Incidence of arrhythmic events in hospitalized HF patients with and without iron deficiency possible
时间窗: through study completion, an average of 1 year
The proportion of hospitalized heart failure patients who experience arrhythmic events (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or clinically significant bradyarrhythmias) during admission. Patients will be categorized based on the presence or absence of iron deficiency (defined by ferritin \<100 ng/mL, or ferritin 100-299 ng/mL with transferrin saturation \<20%).
次要结局
- Resting ECG abnormalities in hospitalized HF patients with and without iron deficiency(through study completion, an average of 1 year)
- Correlation between iron parameters, anemia status, and resting electrophysiologic parameters on 12-lead ECG(through study completion, an average of 1 year)
- Association between iron parameters (and anemia) and electrophysiologic parameters(through study completion, an average of 1 year)
研究者
Samar Mohamed Sadek
Cardiology Resident, Principal Investigator
Assiut University