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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-26

Study Completion Date

2022-03-14

Brief Summary

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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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Detailed Description

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Conditions

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Heart Failure With Reduced Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Empagliflozin arm

37 patients received Empagliflozin 10 mg/day in addition to their guideline-directed medical therapy for HF

Group Type EXPERIMENTAL

Empagliflozin 10 mg

Intervention Type DRUG

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

Placebo arm

37 patients received placebo in addition to their guideline-directed medical therapy for HF

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sugar pills one tablet daily for 6 months

Interventions

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Empagliflozin 10 mg

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

Intervention Type DRUG

Placebo

Sugar pills one tablet daily for 6 months

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No