Empagliflozin and Cardiac Remodeling in People Without Diabetes - EMPA-HEART 2 CardioLink-7

Jan 30, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Boehringer Ingelheim
Date Published:
11/06/2022
Original Posted Date:
01/30/2023
References

Contribution To Literature:

The EMPA-HEART 2 CardioLink-7 trial failed to show that empagliflozin prevented adverse cardiac remodeling.

Description:

The goal of the trial was to evaluate the sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin compared with placebo among patients without diabetes but risk for adverse cardiac remodeling.

Study Design

  • Randomization
  • Parallel
  • Placebo

Patients without diabetes but risk for adverse cardiac remodeling were randomized to empagliflozin 10 mg daily (n = 85) vs. placebo (n = 84).

  • Total number of enrollees: 169
  • Duration of follow-up: 6 months
  • Mean patient age: 59 years
  • Percentage female: 19%

Inclusion criteria:

  • No diabetes, but risk for adverse cardiac remodeling
  • 40-80 years of age

At least one major criteria:

  • Increased LV mass indexed (LVMi) to body surface area
  • ECG evidence of LV hypertrophy
  • Structural heart disease
  • Persistent hypertension

At least one minor criteria:

  • History of myocardial infarction
  • Estimated glomerular filtration rate ≥30 and ≤60 mL·min–1·1.73 m–2
  • Body mass index of ≥27 and ≤40 kg/m2

Exclusion criteria:

  • Type 1 or 2 diabetes
  • Baseline hemoglobin A1c of ≥6.5%
  • History of ketoacidosis or increased risk of developing diabetic ketoacidosis
  • Systolic blood pressure <95 mm Hg
  • Planned coronary revascularization within the next 6 months or coronary revascularization within the preceding 3 months

Principal Findings:

The primary outcome, change in LVMi from baseline to 6 months, was -1.2 g/m2 in the empagliflozin group vs. -1.1 g/m2 in the placebo group (p = 0.74).

Secondary outcomes:

  • Change in LV ejection fraction from baseline to 6 months: 1.3% in the empagliflozin group vs. -0.2% in the placebo group (p = 0.07)
  • At least one adverse event: 26% in the empagliflozin group vs. 19% in the placebo group

Interpretation:

Among patients with diabetes with risk for cardiac remodeling, empagliflozin did not prevent adverse cardiac remodeling. SGLT2 inhibitors have been shown to reduce incident heart failure events among individuals with 1) diabetes and atherosclerotic cardiovascular disease or multiple risk factors, and 2) heart failure with preserved or reduced ejection fraction. Among the lower risk profile of individuals tested in this trial, empagliflozin was not able to improve LVMi or LV ejection fraction.

References:

Connelly KA, Mazer CD, Puar P, 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;147:284-95.

Clinical Topics: Dyslipidemia, Heart Failure and Cardiomyopathies, Prevention, Lipid Metabolism, Acute Heart Failure, Hypertension

Keywords: Body Mass Index, Body Surface Area, Electrocardiography, Glomerular Filtration Rate, Heart Failure, Hypertension, Hypertrophy, Left Ventricular, Myocardial Infarction, Risk, Secondary Prevention, Sodium-Glucose Transporter 2, Sodium-Glucose Transporter 2 Inhibitors, Stroke Volume, Ventricular Remodeling


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