Efficacy and Safety of Lactoferrin in Heart Failure Patients

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Drug: lactoferrin and oral iron; Drug: oral Iron; Drug: Lactoferrin

Study type: Interventional

Funder types: Other

Identifiers

NCT06427200

IHC00072 (Other Identifier)

CL(3530)

Details and patient eligibility

About

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

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

  3. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 3 patient groups

group "oral iron"

Experimental group

Treatment:

Drug: oral Iron

group "lactoferrin"

Experimental group

Treatment:

Drug: Lactoferrin

group "lactoferrin and oral iron"

Experimental group

Treatment:

Drug: lactoferrin and oral iron