Efficacy and Safety of Lactoferrin in Heart Failure Patients

Phase 4

Not yet recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Drug: oral Iron; Drug: lactoferrin and oral iron; Drug: Lactoferrin

• Registration Number: NCT06427200
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-05-18
• Study First Submitted QC: 2024-05-18
• Study First Posted: 2024-05-23
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Study Start: 2024-07
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group "oral iron"	oral Iron	-
group "lactoferrin and oral iron"	lactoferrin and oral iron	-
group "lactoferrin"	Lactoferrin	-

Primary Outcome Measures

Name	Time	Method
Change in health-related quality of life (HR-QoL)	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