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

Alexandria University

Status and phase: Enrolling; Phase 4

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05778084

0107427

Details and patient eligibility

About

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 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Heart failure patients with reduced and mildly reduced ejection fraction

Other group

Description:

* 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.

Treatment:

Drug: Empagliflozin 10 MG