EMPA-HEART2 CardioLink-7
Trial question
What is the role of empagliflozin in patients without diabetes but with risk of adverse cardiac remodeling?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
17.0% female
83.0% male
N = 169
169 patients (28 female, 141 male).
Inclusion criteria: adult patients aged 40-80 years without diabetes but with risk factors for adverse cardiac remodeling.
Key exclusion criteria: type 1 or 2 diabetes; HbA1c ≥ 6.5%, ketoacidosis; SBP < 95 mmHg; planned coronary revascularization within the next 6 months or coronary revascularization within the preceding 3 months.
Interventions
N=85 empagliflozin (at a dose of 10 mg/day for 6 months).
N=84 placebo (matching placebo for 6 months).
Primary outcome
Reduction in left ventricular mass indexed to body surface area at 6 months
1.2 g/m²
1.1 g/m²
1.2 g/m²
0.9 g/m²
0.6 g/m²
0.3 g/m²
0.0 g/m²
Empagliflozin
Placebo
No significant
difference ↔
No significant difference in reduction in LV mass indexed to body surface area at 6 months (1.2 g/m² vs. 1.1 g/m²; AD 0.3 g/m², 95% CI -1.5 to 2.1).
Secondary outcomes
No significant difference in improvement in LVEF at 6 months (1.3% vs. -0.2%; AD 1.5%, 95% CI -0.12 to 3.12).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients aged 40-80 years without diabetes but with risk factors for adverse cardiac remodeling, empagliflozin was not superior to placebo with respect to reduction in LV mass indexed to body surface area at 6 months.
Reference
Kim A Connelly, C David Mazer, Pankaj Puar et al. Empagliflozin and Left Ventricular Remodeling in People Without Diabetes: Primary Results of the EMPA-HEART 2 CardioLink-7 Randomized Clinical Trial. Circulation. 2023 Jan 24;147(4):284-295.
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