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

NCT06065280 | Completed

• 1 other identifier: SGLT2i in Heart Failure
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Reduced Ejection Fraction Heart Failure

Outcome Measures

Primary Outcomes (1)

• Neopterin Concentration

  Neopterin serum level pg/ml

  3 month

Secondary Outcomes (1)

• hospitalization rate

  3 month

Study Arms (2)

Diabetic/HFrEF Group

EXPERIMENTAL

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; Drug: Dapagliflozin 10 MG

Nondiabetic/HFrEF Group

EXPERIMENTAL

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; Drug: Dapagliflozin 10 MG

Interventions

Empagliflozin 10 MG DRUG

Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily.

Also known as: Jardiance 10 mg

Diabetic/HFrEF Group; Nondiabetic/HFrEF Group

Dapagliflozin 10 MG DRUG

Each group will be divided into 2 subgroups one on Empagliflozin and the other one on Dapagliflozin 10 MG daily.

Also known as: Forxiga 10 mg

Diabetic/HFrEF Group; Nondiabetic/HFrEF Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

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

Damanhūr, Elbehairah, 31527, Egypt

Location

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic

Interventions

empagliflozin; dapagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rehab H Werida, Ass Prof.

  Damanhour University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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 )

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 3, 2023
• Study Start: November 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

EG (1)