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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Drug: Empagliflozin 10 MG

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Noha A Hamdy, PhD; Phone Number: +2 01005182151; Email: noha.alaaeldine@alexu.edu.eg
• Study Contact Backup: Name: Rabab Y Kosba, PharmD; Phone Number: +2 01227609096; Email: gs-rabab.kosba@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21521
    • Recruiting
    • Alexandria University
    • Contact: Noha A Hamdy, PhD; Phone Number: +2 01005182151; Email: noha.alaaeldine@alexu.edu.eg
    • Contact: Hisham A Nematalla, PHD; Phone Number: +2 01220512020; Email: hisham.nematalla@pharm.dmu.edu.eg
    • Principal Investigator: Ahmed I Abdel Aaty, PHD
    • Principal Investigator: Ahmed I EL Mallah, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Heart failure patients with reduced and mildly reduced ejection fraction; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NT-ProBNP	Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin level g/dl	Measuring hemoglobin level at baseline and after 6 months	6 months
Leukocytes count	Measuring Leukocytes count at baseline and after 6 months	6 months
Sodium level mg/dl	Measuring serum sodium level at baseline and after 6 months	6 months
Potassium level mg/dl	Measuring serum potassium level at baseline and after 6 months	6 months
Serum Creatinine	Measuring serum creatinine level at baseline and after 6 months	6 months
Ejection Fraction	Measuring Ejection Fraction at baseline and after 6 months	6 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): June 15, 2024
• Study Completion (Anticipated): December 15, 2024

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Empagliflozin; Heart failure with reduced ejection fraction; Nt-proBNP
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 0107427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No