Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction

Study Overview
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Brief Summary
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This study aims to evaluate the relationship between NT-proBNP and empagliflozin effects in patients with chronic heart failure with mildly reduced ejection fraction (HFmrEF 41-49%) and reduced ejection fraction (HFrEF ≤40%) whether diabetic or non-diabetic patients.

Detailed Description
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Ethical Committee approval has been obtained from ethics committee of Faculty of Medicine, Alexandria University. Assigning an informed consent for agreement of participation should be taken by all participants in this clinical study. Heart failure patients with reduced and mildly reduced ejection fraction will be recruited from Alexandria Main University Hospital (AMUH), private hospitals and clinics. A Blood sample will be collected from 60 patients as baseline to test for N-terminal Pro-B-type Natriuretic Peptide. The same 60 patients will take Empagliflozin for 6 months. Another blood sample will be taken from the same 60 patients to test the effect on N-terminal Pro-B-type Natriuretic Peptide after Empagliflozin administration. The appropriate statistical test will be hold according to study design and parameters to evaluate the significant results. Results conclusion discussion and recommendations will be given.

Official Title
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Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction

Conditions
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Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Drug: Empagliflozin 10 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic heart failure with mildly reduced ejection fraction (41-49%) and reduced ejection fraction (≤40%) 18-70 years Not receiving empagliflozin or any SGLT2 inhibitor Elevated plasma NT-proBNP (≥125 pg/ml) eGFR ≥ 20 ml/min/1.73m2 Exclusion Criteria: Acute Coronary Syndrome (ACS) Pulmonary embolism Myocarditis Valvular heart disease Hypertrophic or restrictive cardiomyopathy Congenital heart disease Pulmonary hypertension Surgical procedures involving the heart Heart contusion Cardioversion, Implantable Cardioverter Defibrillator (ICD) shock Patients receiving digoxin Advanced age (>70years) Ischemic stroke Chronic Obstructive Pulmonary Disease Subarachnoid haemorrhage Severe infection (including pneumonia and sepsis) Anemia Renal dysfunction (eGFR <20ml/min/1.73m2) Liver dysfunction (mainly liver cirrhosis with ascites- Child Pugh B & C) Severe burns Paraneoplastic syndrome Severe metabolic and hormone abnormalities (e.g thyrotoxicosis, diabetic ketosis)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open labelled interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Heart failure patients with reduced and mildly reduced ejection fraction<br>One paired test group described as Heart Failure patients with reduced and mildly reduced ejection fraction are indicated for Empagliflozin. Blood samples will be collected as a baseline before Empagliflozin administration to test for N-terminal Pro-B-type Natriuretic Peptide, Followed by administration of empagliflozin for 6 months. Then retest the N-terminal Pro-B-type Natriuretic Peptide after 6 months. | Drug: Empagliflozin 10 MG<br>* Blood samples will be collected as a baseline to test for N-terminal Pro-B-type Natriuretic Peptide, followed by administration of empagliflozin for 6 months, and then another blood samples will be collected after 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-ProBNP | Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level g/dl | Measuring hemoglobin level at baseline and after 6 months | 6 months | 
| Leukocytes count | Measuring Leukocytes count at baseline and after 6 months | 6 months | 
| Sodium level mg/dl | Measuring serum sodium level at baseline and after 6 months | 6 months | 
| Potassium level mg/dl | Measuring serum potassium level at baseline and after 6 months | 6 months | 
| Serum Creatinine | Measuring serum creatinine level at baseline and after 6 months | 6 months | 
| Ejection Fraction | Measuring Ejection Fraction at baseline and after 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Empagliflozin, Heart failure with reduced ejection fraction, Nt-proBNP