Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Empagliflozin, Heart failure with reduced ejection fraction, Nt-proBNP
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.
Interventions
DRUGEmpagliflozin 10 MG
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.
Sponsors
Alexandria University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open labelled interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NT-ProBNP | 6 months | Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leukocytes count | 6 months | Measuring Leukocytes count 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 |
| 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 |
| Potassium level mg/dl | 6 months | Measuring serum potassium level at baseline and after 6 months |
Countries
Egypt
Contacts
Primary ContactRabab Y Kosba, PharmD
Backup ContactNoha A Hamdy, PHD
Outcome results
None listed