Impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction—The EMMY trial

Jan 6, 2020American heart journal

Empagliflozin's effects on heart function and heart failure markers after heart attack

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Abstract

The primary endpoint of the trial is the impact of empagliflozin on changes in NT-proBNP within 6 months after acute myocardial infarction.

Empagliflozin will be tested in a multicenter, randomized, double-blind, placebo-controlled trial involving patients with acute myocardial infarction.
Participants will be randomized in a 1:1 ratio to receive either empagliflozin (10 mg once daily) or a matching placebo.
Secondary endpoints include changes in echocardiographic parameters, levels of ketone bodies, HbA1c levels, and body weight.
Exploratory secondary endpoints will assess hospitalization rates due to heart failure, duration of hospital stay, and all-cause mortality.
The trial aims to investigate the effects of empagliflozin regardless of patients' diabetic status.

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BACKGROUND: Sodium glucose cotransporter 2 (SGLT2) inhibitors are established antidiabetic drugs with proven cardiovascular benefit. Although growing evidence suggests beneficial effects on myocardial remodeling, fluid balance and cardiac function, the impact of empagliflozin initiated early after acute myocardial infarction (AMI) has not been investigated yet. Therefore, the impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction (EMMY) trial was designed to investigate the efficacy and safety of empagliflozin in diabetic and non-diabetic patients after severe AMI.

METHODS: Within a multicenter, randomized, double-blind, placebo-controlled, phase 3b trial we will enroll patients with AMI and characteristics suggestive of severe myocardial necrosis are randomized in a 1:1 ratio to empagliflozin (10 mg once daily) or matching placebo. The primary endpoint is the impact of empagliflozin on changes in NT-proBNP within 6 months after AMI. Secondary endpoints include changes in echocardiographic parameters, levels of ketone body concentrations, HbA1c levels and body weight, respectively. Hospitalization rate due to heart failure or other causes, the duration of hospital stay and all-cause mortality will be assessed as exploratory secondary endpoints.

DISCUSSION: The EMMY trial will test empagliflozin in patients with AMI regardless of their diabetic status. The EMMY trial may therefore underpin the concept of SGLT2 inhibition to improve cardiac remodeling, pre-and afterload reduction and cardiac metabolism regardless of its antidiabetic effects. Results will provide the rationale for the conduct of a cardiovascular outcome trial to test the effect of empagliflozin in patients with AMI.

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Impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction—The EMMY trial

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