NCT06427200Not yet recruitingPhase 4
Efficacy and Safety of Lactoferrin in Heart Failure Patients
Source: ClinicalTrials.gov · Last updated 24 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 18 May 2024
- Start date
- Jul 2024
- Primary completion date
- Jul 2027
- Lead sponsor
- Cairo University
- Diseases
- Heart failure
- NCT number
- NCT06427200
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 114
- From Jul 2024 to the primary completion date, Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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%.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.