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Sodium-glucose Transport 2 Inhibitors (SGLT2i) in HFrEF Patients

Primary Purpose

Heart Failure, Reduced Ejection Fraction Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Empagliflozin 10 MG
Dapagliflozin 10 MG
Sponsored by
Damanhour University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Patients with HFrEF, on optimal medical therapy according to European Society of Cardiology guidelines, an age of at least 18 years, an ejection fraction of 40% or less, with New York Heart Association (NYHA) class II - IV symptoms will be eligible for the study. Exclusion criteria: Recent treatment with or unacceptable side effects associated with an SGLT2i Type-I diabetes mellitus, Symptoms of hypotension or a systolic blood pressure of less than 95 mm Hg, Severe CKD and an estimated glomerular filtration rate (eGFR) below 30 ml per minute per 1.73 m2 of body-surface area or rapidly declining renal function Inability to give informed consent

Sites / Locations

  • Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Diabetic/HFrEF Group

Nondiabetic/HFrEF Group

Arm Description

40 patients with diabetes mellitus patients will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin.

40 patients non-diabetes mellitus group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin.

Outcomes

Primary Outcome Measures

Neopterin Concentration
Neopterin serum level pg/ml

Secondary Outcome Measures

hospitalization rate
hospitalizations duration (days)

Full Information

First Posted
September 27, 2023
Last Updated
October 3, 2023
Sponsor
Damanhour University
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1. Study Identification

Unique Protocol Identification Number
NCT06065280
Brief Title
Sodium-glucose Transport 2 Inhibitors (SGLT2i) in HFrEF Patients
Official Title
Sodium-glucose Transport 2 Inhibitors (SGLT2i) in Heart Failure Reduced Ejection Fraction (HFrEF) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Damanhour 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
The aim of this study is to assess the efficacy, safety and cardiovascular outcomes of Sodium-glucose transport protein 2 inhibitors (SGLT2i) therapy in patients with heart failure reduced ejection fraction ( HFrEF) with and without diabetes mellitus and is to evaluate short-term effect of these drugs using the cardiac biomarkers Neopterin.
Detailed Description
A 3 months, prospective interventional study, which will include 80 patients with established heart failure reduced ejection fraction on optimal standard medical therapy, who will be consecutively randomly allocated to the SGLT2i (10 mg once a day Empagliflozin or Dapagliflozin ) with 40 patients with diabetes mellitus group and 40 patients non-diabetes mellitus group. (Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin ) Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University All patients will undergo : Provided written informed consent and entered a 10-day screening period, during which the trial inclusion and exclusion criteria were checked and baseline information gathered. Complete history with NYHA class assessment and clinical examination before and after the study 12-lead ECG before and after the study Complete Echocardiography study before and after the study Baseline venous sampling for urea, creatinine, potassium ,CBC , fasting blood sugar and Hemoglobin A1C at the beginning of the study and after 3 months of the study Measurements of Neopterin by ELISA at the beginning of the of the study and after 3 months of the study Outcomes : Clinical outcomes, all patients will be followed up for 3 months for: 1ry outcomes: A)Complete Echocardiography monitoring for improvements B) Level of Neopterin C)will be a composite of worsening heart failure requiring hospitalization and/ or death from cardiovascular causes. 2ry outcomes: A) will be the additional secondary outcomes were the total number of hospitalizations for heart failure B) functional capacity and quality of life by the Kansas City Cardiomyopathy Questionnaire (KCCQ) reflects key health status. C) a composite of worsening renal function, which will defined as a sustained decline in the eGFR of 50% or greater, end-stage renal disease (defined as a sustained [≥28 days] eGFR of <15 ml per minute per 1.73 m2, sustained dialysis, or renal transplantation), or renal death; and death from any cause. • Safety outcomes : included serious adverse events, adverse events associated with the discontinuation of a trial treatment, adverse events of interest (i.e., volume depletion, renal events, major hypoglycemic events, diabetic ketoacidosis, dizziness , syncope ,acute renal failure or dialysis and laboratory findings of note, hypoglycemia and hypokalemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Reduced Ejection Fraction Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
80 patients with established heart failure reduced ejection fraction on optimal standard medical therapy, who will be consecutively randomly allocated to the SGLT2i (10 mg once a day Empagliflozin or Dapagliflozin ) with 40 patients with diabetes mellitus group and 40 patients non-diabetes mellitus group. (Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin )
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetic/HFrEF Group
Arm Type
Experimental
Arm Description
40 patients with diabetes mellitus patients will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin.
Arm Title
Nondiabetic/HFrEF Group
Arm Type
Experimental
Arm Description
40 patients non-diabetes mellitus group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin.
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Other Intervention Name(s)
Jardiance 10 mg
Intervention Description
Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10 MG
Other Intervention Name(s)
Forxiga 10 mg
Intervention Description
Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily.
Primary Outcome Measure Information:
Title
Neopterin Concentration
Description
Neopterin serum level pg/ml
Time Frame
3 month
Secondary Outcome Measure Information:
Title
hospitalization rate
Description
hospitalizations duration (days)
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with HFrEF, on optimal medical therapy according to European Society of Cardiology guidelines, an age of at least 18 years, an ejection fraction of 40% or less, with New York Heart Association (NYHA) class II - IV symptoms will be eligible for the study. Exclusion criteria: Recent treatment with or unacceptable side effects associated with an SGLT2i Type-I diabetes mellitus, Symptoms of hypotension or a systolic blood pressure of less than 95 mm Hg, Severe CKD and an estimated glomerular filtration rate (eGFR) below 30 ml per minute per 1.73 m2 of body-surface area or rapidly declining renal function Inability to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab H Werida, Ass. Prof.
Phone
+201005359968
Email
rehabwrieda@pharm.dmu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Dina T. Elhamamy
Email
Dinatarek790@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab H Werida, Ass Prof.
Organizational Affiliation
Damanhour University
Official's Role
Study Chair
Facility Information:
Facility Name
Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
City
Damanhūr
State/Province
Elbehairah
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab H Werida, Ass. Prof.
Phone
01005359968
Email
rehabwrieda@pharm.dmu.edu.eg
First Name & Middle Initial & Last Name & Degree
Dina T. Elhamamy, Bachlor
Email
Dinatarek790@gmail.com

12. IPD Sharing Statement

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Sodium-glucose Transport 2 Inhibitors (SGLT2i) in HFrEF Patients

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