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Completed

NCT Number: NCT06632561

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

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beni-Suef University

BeniSuef, 62521, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empagliflozin 10 MG

Drug

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

Placebo

Drug

Sugar pills one tablet daily for 6 months

Primary outcomes

  1. The changes in LV volumes (mL)

    Time frame: 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.

  2. The changes in of Left Ventricular Ejection Fraction (LVEF) (%)

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. The changes in 6 minute walk test (meters)

    Time frame: 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.

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

    Time frame: 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.

Other outcomes

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

    Time frame: From enrollment to the end of treatment at 6 months

    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.

Sponsors and collaborators

Lead sponsor

Ashraf Wasfy Beshay Aziz

Other

Registry information

Acronym: HFrEF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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