DRUG
Empagliflozin 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.
Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction
Status
Unknown
Phase
Phase 4
Enrollment
60
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 21, 2023
Study start
Dec 15, 2022
Primary completion
Jun 15, 2024
Study completion
Dec 15, 2024
Results posted
Not reported
Registry updated
Mar 21, 2023
Outcomes
What the study measures.
Primary outcomes
NT-ProBNP
Time frame · 6 months
Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months
Secondary outcomes
Hemoglobin level g/dl
Time frame · 6 months
Measuring hemoglobin level at baseline and after 6 months
Leukocytes count
Time frame · 6 months
Measuring Leukocytes count at baseline and after 6 months
Sodium level mg/dl
Time frame · 6 months
Measuring serum sodium level at baseline and after 6 months
Potassium level mg/dl
Time frame · 6 months
Measuring serum potassium level at baseline and after 6 months
Serum Creatinine
Time frame · 6 months
Measuring serum creatinine level at baseline and after 6 months
Ejection Fraction
Time frame · 6 months
Measuring Ejection Fraction at baseline and after 6 months
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Sex
- ALL
- 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)
Study locations
1 registered sites.
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Alexandria University
Alexandria, Egypt
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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