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

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Empagliflozin 10 MG
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Empagliflozin, Heart failure with reduced ejection fraction, Nt-proBNP

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Alexandria UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Heart failure patients with reduced and mildly reduced ejection fraction

Arm 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.

Outcomes

Primary Outcome Measures

NT-ProBNP
Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2023
Last Updated
March 9, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05778084
Brief Title
Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction
Official Title
Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Ethical Committee approval has been obtained from ethics committee of Faculty of Medicine, Alexandria University. Assigning an informed consent for agreement of participation should be taken by all participants in this clinical study. Heart failure patients with reduced and mildly reduced ejection fraction will be recruited from Alexandria Main University Hospital (AMUH), private hospitals and clinics. A Blood sample will be collected from 60 patients as baseline to test for N-terminal Pro-B-type Natriuretic Peptide. The same 60 patients will take Empagliflozin for 6 months. 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. The appropriate statistical test will be hold according to study design and parameters to evaluate the significant results. Results conclusion discussion and recommendations will be given.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
Empagliflozin, Heart failure with reduced ejection fraction, Nt-proBNP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open labelled interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart failure patients with reduced and mildly reduced ejection fraction
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Intervention Description
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.
Primary Outcome Measure Information:
Title
NT-ProBNP
Description
Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hemoglobin level g/dl
Description
Measuring hemoglobin level at baseline and after 6 months
Time Frame
6 months
Title
Leukocytes count
Description
Measuring Leukocytes count at baseline and after 6 months
Time Frame
6 months
Title
Sodium level mg/dl
Description
Measuring serum sodium level at baseline and after 6 months
Time Frame
6 months
Title
Potassium level mg/dl
Description
Measuring serum potassium level at baseline and after 6 months
Time Frame
6 months
Title
Serum Creatinine
Description
Measuring serum creatinine level at baseline and after 6 months
Time Frame
6 months
Title
Ejection Fraction
Description
Measuring Ejection Fraction at baseline and after 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rabab Y Kosba, PharmD
Phone
01227609096
Ext
+2
Email
gs-rabab.kosba@alexu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Noha A Hamdy, PHD
Phone
01005182151
Ext
+2
Email
Noha.alaaeldine@alexu.edu.eg
Facility Information:
Facility Name
Alexandria University
City
Alexandria
ZIP/Postal Code
21521
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noha A Hamdy, PHD
Phone
01005182151
Ext
+2
Email
Noha.alaaeldine@alexu.edu.eg
First Name & Middle Initial & Last Name & Degree
Hisham A Nematalla, PHD
Phone
01220512020
Ext
+2
Email
hisham.nematalla@pharm.dmu.edu.eg
First Name & Middle Initial & Last Name & Degree
Ahmed I Abdel Aaty, PHD
First Name & Middle Initial & Last Name & Degree
Ahmed I EL Mallah, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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