Efficacy and Safety of Lactoferrin in Heart Failure Patients

NCT06427200 | Not Yet Recruiting Phase 4

• 2 other identifiers: CL(3530)IHC00072
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Lactoferrin; oral iron; reduced ejection fraction; iron deficiency; heart failure; clinical trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

group "oral iron"

EXPERIMENTAL

Drug: oral Iron

group "lactoferrin"

EXPERIMENTAL

Drug: Lactoferrin

group "lactoferrin and oral iron"

EXPERIMENTAL

Drug: lactoferrin and oral iron

Interventions

oral Iron DRUG

oral iron once daily during or after meals as add-on therapy for 12 weeks.

group "oral iron"

Lactoferrin DRUG

lactoferrin twice daily before meals as add-on therapy for 12 weeks.

group "lactoferrin"

lactoferrin and oral iron DRUG

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

group "lactoferrin and oral iron"

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• \. Arrythmia including atrial fibrillation (AF) with poorly controlled ventricular rate at rest (\> 100 beats/min).
• \. 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).
• \. 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Iron Deficiencies; Heart Failure

Interventions

Iron; Lactoferrin

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at Faculty of Pharmacy Cairo University

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 23, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 24, 2024

Record last verified: 2024-01