Efficacy and Safety of Lactoferrin in Heart Failure Patients

May 23, 2024 updated by: reham mohamed saied salem, Cairo University

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group "oral iron"
Drug: oral Iron
oral iron once daily during or after meals as add-on therapy for 12 weeks.
Experimental: group "lactoferrin"
Drug: Lactoferrin
lactoferrin twice daily before meals as add-on therapy for 12 weeks.
Experimental: group "lactoferrin and oral iron"
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 18, 2024

First Submitted That Met QC Criteria

May 18, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL(3530)
  • IHC00072 (Other Identifier: the general organization for teaching hospitals and institutes (GOTHI))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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