Benefits of Empagliflozin in Patients With Heart Failure... | NCT06632561

NCT06632561

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Empagliflozin arm	Experimental	37 patients received Empagliflozin 10 mg/day in addition to their guideline-directed medical therapy for HF	Drug: Empagliflozin 10 mg
Placebo arm	Placebo Comparator	37 patients received placebo in addition to their guideline-directed medical therapy for HF	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Empagliflozin 10 mg	Drug	Empagliflozin (a sodium-glucose cotransporter-2 inhibitor) 10 mg one tablet daily dose for 6 months	Empagliflozin arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The changes in LV volumes (mL)	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.	From enrollment to the end of treatment at 6 months
The changes in of Left Ventricular Ejection Fraction (LVEF) (%)	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.	From enrollment to the end of treatment at 6 months

Secondary Outcomes

Measure	Description	Time Frame
The changes in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL)	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.

Other Outcomes

Measure	Description	Time Frame
a (five points or more) improvement in the Minnesota Living with Heart Failure Questionnaire	Since a five point change in MLHFQ is considered clinically meaningful, we have performed an exploratory analysis to compare the proportion of patients with ≥5 points improvement in MLHFQ in both groups.	From enrollment to the end of treatment at 6 months

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Hesham B Mahmoud, Professor of Cardiology	Beni-Suef University	Study Chair
Mohammad Sh Awad, Assistant Professor Cardiology	Beni-Suef University	Study Director
Mohammed M Tohamy, Lecturer of Cardiology	Beni-Suef University	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Beni-Suef University		BeniSuef		62521	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33197559	Background	Santos-Gallego CG, Vargas-Delgado AP, Requena-Ibanez JA, Garcia-Ropero A, Mancini D, Pinney S, Macaluso F, Sartori S, Roque M, Sabatel-Perez F, Rodriguez-Cordero A, Zafar MU, Fergus I, Atallah-Lajam F, Contreras JP, Varley C, Moreno PR, Abascal VM, Lala A, Tamler R, Sanz J, Fuster V, Badimon JJ; EMPA-TROPISM (ATRU-4) Investigators. Randomized Trial of Empagliflozin in Nondiabetic Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2021 Jan 26;77(3):243-255. doi: 10.1016/j.jacc.2020.11.008. Epub 2020 Nov 13.