Efficacy and Safety of Lactoferrin in Heart Failure Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oral Iron, Lactoferrin, lactoferrin and oral iron.
- Who it may be relevant to
- Registry conditions: Heart Failure With Reduced Ejection Fraction. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug oral Iron
oral iron once daily during or after meals as add-on therapy for 12 weeks. - Drug Lactoferrin
lactoferrin twice daily before meals as add-on therapy for 12 weeks. - Drug 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.
Primary outcome measures
- Change in health-related quality of life (HR-QoL) [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- 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%.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06427200 · CL(3530) · IHC00072