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

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

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.

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

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)