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

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778084
• Other study ID #: 0107427
• Status: Recruiting
• Phase: Phase 4
• Start date: December 15, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: October 2022
• Source: Alexandria University
• Contact: Rabab Y Kosba, PharmD
• Phone: 01227609096
• Email: gs-rabab.kosba[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

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.

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NT-ProBNP	Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months	6 months
Secondary	Hemoglobin level g/dl	Measuring hemoglobin level at baseline and after 6 months	6 months
Secondary	Leukocytes count	Measuring Leukocytes count at baseline and after 6 months	6 months
Secondary	Sodium level mg/dl	Measuring serum sodium level at baseline and after 6 months	6 months
Secondary	Potassium level mg/dl	Measuring serum potassium level at baseline and after 6 months	6 months
Secondary	Serum Creatinine	Measuring serum creatinine level at baseline and after 6 months	6 months
Secondary	Ejection Fraction	Measuring Ejection Fraction at baseline and after 6 months	6 months