Clinical trial NCT06632561: Benefits of Empagliflozin in Patients With Heart Failure and Reduced Ejection Fraction Without Diabetes Mellitus
Official title: Benefits of Empagliflozin in Patients With Heart Failure and Reduced Ejection Fraction Without Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The changes in LV volumes (mL)
timeFrame: From enrollment to the end of treatment at 6 months
measure: The changes in of Left Ventricular Ejection Fraction (LVEF) (%)
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: The changes in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL)
timeFrame: From enrollment to the end of treatment at 6 months
measure: The changes in 6 minute walk test (meters)
timeFrame: From enrollment to the end of treatment at 6 months
measure: The changes in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (points)
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
measure: a (five points or more) improvement in the Minnesota Living with Heart Failure Questionnaire
timeFrame: From enrollment to the end of treatment at 6 months
Locations:
city: BeniSuef
country: Egypt
facility: Beni-Suef University
Study officials:
affiliation: Beni-Suef University
name: Hesham B Mahmoud, Professor of Cardiology
role: STUDY_CHAIR
affiliation: Beni-Suef University
name: Mohammad Sh Awad, Assistant Professor Cardiology
role: STUDY_DIRECTOR
affiliation: Beni-Suef University
name: Mohammed M Tohamy, Lecturer of Cardiology
role: STUDY_DIRECTOR
References:
citation: 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.