Efficacy and Safety of Lactoferrin in Heart Failure Patients

Launched by CAIRO UNIVERSITY · May 18, 2024

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18-65 years old.
• • 2. Chronic heart failure (\> 6 months duration) with reduced ejection fraction defined as LVEF ≤ 40%.
• • 3. NYHA-class II or III or IV with stable symptoms for at least the past 3 months.
• • 4. 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.
• • 5. No dose changes of heart failure drugs during the last 2 weeks (exception: diuretics)
• • 6. No introduction of a new heart failure drug class during the last 4 weeks.
• • 7. 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%.
• Exclusion Criteria:
• • 1. Arrythmia including atrial fibrillation (AF) with poorly controlled ventricular rate at rest (\> 100 beats/min).
• • 2. Recent cardiac related hospitalizations in the past 3 months. 3. Known active infection. 4. 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).
• • 5. Associated bleeding disorder. 6. Previous iron supplement in past 3 months. 7. Anemia requiring blood transfusion (haemoglobin (Hb) \< 7 g/dL). 8. Folic acid or vitamin B12 deficiency. 9. Hypersensitivity to lactoferrin or iron. 10. Haemoglobinopathies (G6PD, thalassemia's, sickle cell disease). 11. Pregnancy and lactation.