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

January 18, 2024 updated by: Rehab Werida, Damanhour University

Sodium-glucose Transport 2 Inhibitors (SGLT2i) in Heart Failure Reduced Ejection Fraction (HFrEF) Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Elbehairah
      • Damanhūr, Elbehairah, Egypt, 31527
        • Recruiting
        • Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetic/HFrEF Group
40 patients with diabetes mellitus patients will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin.
Drug: Empagliflozin 10 MG
Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily.
Other Names:
  • Jardiance 10 mg
Drug: Dapagliflozin 10 MG
Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily.
Other Names:
  • Forxiga 10 mg
Experimental: Nondiabetic/HFrEF Group
40 patients non-diabetes mellitus group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin.
Drug: Empagliflozin 10 MG
Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily.
Other Names:
  • Jardiance 10 mg
Drug: Dapagliflozin 10 MG
Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily.
Other Names:
  • Forxiga 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neopterin Concentration
Time Frame: 3 month
Neopterin serum level pg/ml
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospitalization rate
Time Frame: 3 month
hospitalizations duration (days)
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Study Chair: Rehab H Werida, Ass Prof., Damanhour University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGLT2i in Heart Failure

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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