NCT05778084

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-15
• Primary completion: 2024-06-15
• Completion: 2024-12-15
• First posted: 2023-03-21
• Last updated: 2023-03-21

Locations

1 site across 1 country: Egypt