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

NCT06632561 | Completed Phase 4

• 1 other identifier: FMBSUREC/06072021/Aziz
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• 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 (3)

• 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

• The changes in 6 minute walk test (meters)

  From enrollment to the end of treatment at 6 months

• The changes in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (points)

  From enrollment to the end of treatment at 6 months

Other Outcomes (1)

• a (five points or more) improvement in the Minnesota Living with Heart Failure Questionnaire

  From enrollment to the end of treatment at 6 months

Study Arms (2)

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

Interventions

Empagliflozin 10 mg DRUG

Empagliflozin (a sodium-glucose cotransporter-2 inhibitor) 10 mg one tablet daily dose for 6 months

Empagliflozin arm

Placebo DRUG

Sugar pills one tablet daily for 6 months

Placebo arm

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ashraf Wasfy Beshay Aziz: lead

Study Sites (1)

Beni-Suef University

BeniSuef, 62521, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33197559 BACKGROUND

MeSH Terms

Interventions

empagliflozin

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiology Specialist

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 9, 2024
• Study Start: July 26, 2021
• Primary Completion: March 9, 2022
• Study Completion: March 14, 2022
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)