## Protocol Section
### Identification Module
**NCT ID:** NCT06427200

**Brief Title:** Efficacy and Safety of Lactoferrin in Heart Failure Patients

**Official Title:** Efficacy and Safety of Lactoferrin in Heart Failure Patients

#### Organization Study ID Info
**ID:** CL(3530)
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
#### Secondary ID Infos
**Domain:** the general organization for teaching hospitals and institutes (GOTHI)
**ID:** IHC00072
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** reham mohamed saied salem

**Investigator Title:** Teaching assistant at Faculty of Pharmacy Cairo University

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**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 Module

**Conditions:**

- Heart Failure With Reduced Ejection Fraction

**Keywords:**

- Lactoferrin

- oral iron

- reduced ejection fraction

- iron deficiency

- heart failure

- clinical trial

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 114

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: oral Iron

**Label:** group "oral iron"

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Lactoferrin

**Label:** group "lactoferrin"

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: lactoferrin and oral iron

**Label:** group "lactoferrin and oral iron"

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group "oral iron"

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

**Name:** oral Iron

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- group "lactoferrin"

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

**Name:** Lactoferrin

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- group "lactoferrin and oral iron"

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

**Name:** lactoferrin and oral iron

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** • 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

**Measure:** Change in health-related quality of life (HR-QoL)

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M20857

- Name: Anemia, Iron-Deficiency

- Relevance: LOW

- As Found: Unknown

- ID: M2781

- Name: Iron Deficiencies

- Relevance: LOW

- As Found: Unknown

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Intervention Browse Module - Ancestors

- ID: D000014131

- Term: Trace Elements

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M10799

- Name: Lactoferrin

- Relevance: HIGH

- As Found: Peripheral Neuropathy

- ID: M10533

- Name: Iron

- Relevance: HIGH

- As Found: Gastric

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007501

- Term: Iron

- ID: D000007781

- Term: Lactoferrin

### Misc Info Module

- Version Holder: 2024-05-31
