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

Ashraf Wasfy Beshay Aziz

Status and phase

Completed

Phase 4

Conditions

Heart Failure With Reduced Ejection Fraction

Treatments

Drug: Empagliflozin 10 mg

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06632561

FMBSUREC/06072021/Aziz

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.