Benefits of Empagliflozin in Patients With Heart Failure and Reduced Ejection Fraction Without Diabetes Mellitus

Phase 4

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Drug: Empagliflozin 10 mg; Drug: Placebo

• Registration Number: NCT06632561
• Lead Sponsor: Ashraf Wasfy Beshay Aziz

Brief Summary

The study is a short to mid-term randomized single-blind placebo controlled study that aimed to detect the effects of empagliflozin (a sodium-glucose cotransporter-2 inhibitor) compared to placebo on LV end-diastolic and end-systolic volumes, LV ejection fraction, N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity and quality of life (QoL) among non-diabetic patients with HFrEF.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-26
• Primary Completion: 2022-03-09
• Study Completion: 2022-03-14
• Status Verified: 2024-10
• Study First Submitted: 2024-10-06
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Ambulatory non-diabetic adult male and non-pregnant female patients with established diagnosis of heart failure (HF) New York Heart Association functional class II-IV and left ventricular ejection fraction (LVEF) ≤ 40% (calculated by echocardiography within the previous 6 months before randomization).
• Patients should have stable symptoms and stable guideline-directed medical therapy for HF within the last 3 months before randomization. It was mandatory that all patients have reached the maximum tolerated doses of guideline-directed medical therapy for HF and are regular on them for at least 3 months before participation.
• Patients were not known to be diabetic and have no history of diabetes remission and their baseline glycosylated hemoglobin (HbA1c) should have been < 5.7%.
• Patients have never been on SGLT2 inhibitor therapy before.
• Estimated glomerular filtration rate (eGFR) should have been ≥ 45 mL/min/1.73 m² using the chronic kidney disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2009)

Exclusion Criteria

• Women who were pregnant at time of selection, possibly pregnant, breast-feeding, or planning to become pregnant during the study period.
• Patients who had acute coronary syndrome, cardiac surgery, stroke or transient ischemic attack (TIA) within the last 3 months before randomization.
• Patients who had infiltrative cardiomyopathy, muscular dystrophies, hypertrophic cardiomyopathy, peripartum cardiomyopathy, pericardial restriction or chemotherapy induced cardiomyopathy within 12 months before randomization.
• Patients with severe valvular heart disease.
• Patients who had acute decompensated HF or were on continuous parenteral inotropic agents with 3 months before randomization.
• Patients who had cardiac resynchronization therapy (CRT) implantation within 3 months before randomization.
• History of recurrent urinary tract infection, cancer or any life threatening condition or psychiatric disease incompatible with being in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin arm	Empagliflozin 10 mg	37 patients received Empagliflozin 10 mg/day in addition to their guideline-directed medical therapy for HF
Placebo arm	Placebo	37 patients received placebo in addition to their guideline-directed medical therapy for HF

Primary Outcome Measures

Name	Time	Method
The changes in LV volumes (mL)	From enrollment to the end of treatment at 6 months	To measure the changes in of Left Ventricular end-diastolic volume (LVEDV) (mL) and Left Ventricular end-systolic volume (LVESV) (mL) via transthoracic echocardiography using the modified Simpson's rule (the biplane disk summation approach).; Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.
The changes in of Left Ventricular Ejection Fraction (LVEF) (%)	From enrollment to the end of treatment at 6 months	To measure the changes in of Left Ventricular Ejection Fraction (LVEF) (%) via transthoracic echocardiography using the modified Simpson's rule (the biplane disk summation approach).; Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.

Secondary Outcome Measures

Name	Time	Method
The changes in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL)	From enrollment to the end of treatment at 6 months	Measurement of N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL) at baseline and at the end of treatment phase after 6 months within both study arms via the electrochemiluminescence immunoassay "ECLIA".; Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.
The changes in 6 minute walk test (meters)	From enrollment to the end of treatment at 6 months	Measurement of 6 minute walk test (meters) at baseline and at the end of treatment phase after 6 months within both study arms.; Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.
The changes in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (points)	From enrollment to the end of treatment at 6 months	Measurement of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (points) at baseline and at the end of treatment phase after 6 months within both study arms.; Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups.

Trial Locations

Locations (1)

Beni-Suef University; 🇪🇬 BeniSuef, Egypt