Heart Failure With Reduced Ejection FractionPhase 4NCT06427200
Efficacy and Safety of Lactoferrin in Heart Failure Patients
A Phase 4 study testing oral Iron, Lactoferrin and lactoferrin and oral iron in people with Heart Failure With Reduced Ejection Fraction, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- oral Iron, Lactoferrin and lactoferrin and oral iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
About this study
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
- Being tested
- oral Iron, Lactoferrin, lactoferrin and oral iron
- Keywords
- Lactoferrin, oral iron, reduced ejection fraction, iron deficiency, heart failure, clinical trial
- Medical subject headings
- Iron Deficiencies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral IronDrug
oral iron once daily during or after meals as add-on therapy for 12 weeks.
LactoferrinDrug
lactoferrin twice daily before meals as add-on therapy for 12 weeks.
lactoferrin and oral ironDrug
lactoferrin twice daily before meals and oral iron once daily during or after meals as add-on therapy for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| group "oral iron" | Experimental | Not described Receives: Drug: oral Iron |
| group "lactoferrin" | Experimental | Not described Receives: Drug: Lactoferrin |
| group "lactoferrin and oral iron" | Experimental | Not described Receives: Drug: lactoferrin and oral iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reham mohamed saied salem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427200
- Sponsor's protocol ID
- CL(3530)
- Other IDs
- IHC00072
- Status last verified
- Jan 2024
- First submitted
- 18 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lactoferrin in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06427200
- Acronym / sponsor ID
- CL(3530)
- Keywords
- Lactoferrin, oral iron, reduced ejection fraction, iron deficiency, heart failure, clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group "oral iron" | Experimental | Drug: oral Iron |
| group "lactoferrin" | Experimental | Drug: Lactoferrin |
| group "lactoferrin and oral iron" | Experimental | Drug: lactoferrin and oral iron |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral Ironoral iron once daily during or after meals as add-on therapy for 12 weeks. | Drug | group "oral iron" |
| Lactoferrinlactoferrin twice daily before meals as add-on therapy for 12 weeks. | Drug | group "lactoferrin" |
| lactoferrin and oral ironlactoferrin twice daily before meals and oral iron once daily during or after meals as add-on therapy for 12 weeks. | Drug | group "lactoferrin and oral iron" |
Primary outcome
Change in health-related quality of life (HR-QoL)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral Iron, Lactoferrin and lactoferrin and oral iron in people with Heart Failure With Reduced Ejection Fraction, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related quality of life (HR-QoL) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.