ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2020
Placebo-Controlled, Double-Blind Study of Empagliflozin (EMPA) and Implantable Cardioverter-Defibrillator (EMPA-ICD) in Patients with Type 2 Diabetes (T2DM): Rationale and Design.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 21 citations in OpenAlex.
- The effects of empagliflozin on ventricular arrhythmias in heart failure patients with an implantable cardioverter-defibrillator: a double-blind randomized controlled trial.Naunyn-Schmiedeberg's archives of pharmacology · 2024Trial
- Effect of empagliflozin on ventricular arrhythmias in patients with type 2 diabetes treated with an implantable cardioverter-defibrillator: the EMPA-ICD trial.Cardiovascular diabetology · 2024Trial
- The impact of sodium glucose cotransporter-2 inhibitors on ventricular arrhythmia in patients with implantable cardioverter-defibrillators: a meta analysis.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Review
- Antiarrhythmic Effects of SGLT2 Inhibitors on Supraventricular Tachyarrhythmias in Patients with HFrEF.Journal of clinical medicine · 2025Article
- Anti-Arrhythmic Effects of Heart Failure Guideline-Directed Medical Therapy and Their Role in the Prevention of Sudden Cardiac Death: From Beta-Blockers to Sodium-Glucose Cotransporter 2 Inhibitors and Beyond.Journal of clinical medicine · 2024Review
- Potential favorable action of sodium-glucose cotransporter-2 inhibitors on sudden cardiac death: a brief overview.Frontiers in cardiovascular medicine · 2023Review
- SGLT2 Inhibitors and Their Antiarrhythmic Properties.International journal of molecular sciences · 2022Review
- Antiarrhythmic effects and mechanisms of sodium-glucose cotransporter 2 inhibitors: A mini review.Frontiers in cardiovascular medicine · 2022Review
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Authors and funding
41 authors at 20 institutions in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
introductionType 2 diabetes (T2DM) is associated with cardiovascular death, including sudden cardiac death due to arrhythmias. Patients with an implantable cardioverter-defibrillator (ICD) are also at high risk of developing a clinically significant ventricular arrhythmia. It has been reported that sodium-glucose cotransporter 2 (SGLT2) inhibitors can reduce cardiovascular deaths; however, the physiological mechanisms of this remain unclear. It is, however, well known that SGLT2 inhibitors increase blood ketone bodies, which have been suggested to have sympatho-suppressive effects. Empagliflozin (EMPA) is an SGLT2 inhibitor. The current clinical trial titled "Placebo-controlled, double-blind study of empagliflozin (EMPA) and implantable cardioverter-defibrillator (EMPA-ICD) in patients with type 2 diabetes (T2DM)" was designed to investigate the antiarrhythmic effects of EMPA.
methodsThe EMPA-ICD study is a prospective, multicenter, placebo-controlled, double-blind, randomized, investigator-initiated clinical trial currently in progress. A total of 210 patients with T2DM (hemoglobin A1c 6.5-10.0%) will be randomized (1:1) to receive once-daily placebo or EMPA, 10 mg, for 24 weeks. The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD. The secondary endpoints of the study are the change from baseline concentrations in blood ketone and catecholamine 24 weeks after drug treatment.
conclusionThe EMPA-ICD study is the first clinical trial to assess the effect of an SGLT2 inhibitor on clinically significant ventricular arrhythmias in patients with T2DM and an ICD.
trial registrationUnique trial number, jRCTs031180120 ( https://jrct.niph.go.jp/latest-detail/jRCTs031180120 ).
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