Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- Registration Number
- NCT05778084
- Lead Sponsor
- Alexandria University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Heart failure patients with reduced and mildly reduced ejection fraction Empagliflozin 10 MG * 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.
- Primary Outcome Measures
Name Time Method NT-ProBNP 6 months Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months
- Secondary Outcome Measures
Name Time Method Potassium level mg/dl 6 months Measuring serum potassium level at baseline and after 6 months
Sodium level mg/dl 6 months Measuring serum sodium level at baseline and after 6 months
Hemoglobin level g/dl 6 months Measuring hemoglobin level at baseline and after 6 months
Leukocytes count 6 months Measuring Leukocytes count at baseline and after 6 months
Serum Creatinine 6 months Measuring serum creatinine level at baseline and after 6 months
Ejection Fraction 6 months Measuring Ejection Fraction at baseline and after 6 months
Trial Locations
- Locations (1)
Alexandria University
🇪🇬Alexandria, Egypt