NCT06427200尚未招募4 期
Efficacy and Safety of Lactoferrin in Heart Failure Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 114
- 主要终点
- Change in health-related quality of life (HR-QoL)
研究概览
简要总结
This study will be conducted to determine the efficacy and safety of lactoferrin versus oral iron versus lactoferrin plus oral iron as an add on therapy in reduced ejection fraction heart failure patients with iron deficiency.
•Patients will be randomly distributed into the three groups
- All patients will be subjected to baseline data assessment
- Follow up after 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years old.
- •Chronic heart failure (> 6 months duration) with reduced ejection fraction defined as LVEF ≤ 40%.
- •NYHA-class II or III or IV with stable symptoms for at least the past 3 months.
- •Stabilized on beta blockers, renin-angiotensin system inhibitor (ACEI/ARB) or angiotensin receptor-neprilysin inhibitors (ARNIs), mineralocorticoid receptor antagonists (MRAs) and sodium-glucose co-transporter 2 Inhibitors (SGLT2i) and diuretics as needed.
- •No dose changes of heart failure drugs during the last 2 weeks (exception: diuretics)
- •No introduction of a new heart failure drug class during the last 4 weeks.
- •Iron deficiency: serum ferritin level of 15 to 100 ng/mL or a serum ferritin level of 101 to 299 ng/mL with transferrin saturation of less than 20%.
排除标准
- •Arrythmia including atrial fibrillation (AF) with poorly controlled ventricular rate at rest (> 100 beats/min).
- •Recent cardiac related hospitalizations in the past 3 months.
- •Known active infection.
- •Associated chronic medical disorder (chronic kidney disease (creatinine clearance < 60 ml/min), liver disease (ALT or AST > 3× upper limit of normal), peptic ulcer or chronic blood loss).
- •Associated bleeding disorder.
- •Previous iron supplement in past 3 months.
- •Anemia requiring blood transfusion (haemoglobin (Hb) < 7 g/dL).
- •Folic acid or vitamin B12 deficiency.
- •Hypersensitivity to lactoferrin or iron.
- •Haemoglobinopathies (G6PD, thalassemia's, sickle cell disease).
- •Pregnancy and lactation.
研究组 & 干预措施
group "oral iron"
Experimental
干预措施: oral Iron (Drug)
group "lactoferrin"
Experimental
干预措施: Lactoferrin (Drug)
group "lactoferrin and oral iron"
Experimental
干预措施: lactoferrin and oral iron (Drug)
结局指标
主要结局
Change in health-related quality of life (HR-QoL)
时间窗: 3 months
• Change in health-related quality of life (HR-QoL) as evaluated by Minnesota Living with Heart Failure Questionnaire (MLHFQ) minimum score:0 maximum score:105 minimum score is a better outcome
次要结局
未报告次要终点
研究者
reham mohamed saied salem
Teaching assistant at Faculty of Pharmacy Cairo University
Cairo University
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