Efficacy and Safety of Lactoferrin in Heart Failure Patients

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

Efficacy and Safety of Lactoferrin in Heart Failure Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427200
• Other study ID #: CL(3530)
• Secondary ID: IHC00072
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2024
• Est. completion date: July 2027

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Drug:
• oral Iron
oral iron once daily during or after meals as add-on therapy for 12 weeks.
• Lactoferrin
lactoferrin twice daily before meals as add-on therapy for 12 weeks.
• lactoferrin and oral iron
lactoferrin twice daily before meals and oral iron once daily during or after meals as add-on therapy for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in health-related quality of life (HR-QoL)	• 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	3 months