This study investigates the effects of ertugliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), on arrhythmic burden in patients with heart failure and reduced ejection fraction who have implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy devices (CRT-Ds). Despite early termination due to updated guideline recommendations, the results suggest a potential reduction in sustained ventricular arrhythmias with ertugliflozin treatment.
Study Design:
- Multicenter, double-blind, randomized, placebo-controlled trial
- Participants: Patients with heart failure (ejection fraction <50%) and ICD/CRT-D
- Intervention: Ertugliflozin 5 mg once daily vs. placebo
- Primary endpoint: Number of incident sustained (>30 seconds) ventricular tachycardia or ventricular fibrillation events from baseline to week 52
- Secondary endpoints: Non-sustained ventricular tachycardias, appropriate ICD therapies, changes in NTproBNP levels, heart failure hospitalizations
- Study terminated early with 46 patients enrolled (11% of planned sample size)
Key Findings:
- Primary endpoint: Yearly rate of sustained ventricular arrhythmias was significantly lower with ertugliflozin (3.5 events, 95% CI 2.8-4.4) compared to placebo (13.3 events, 95% CI 11.8-14.8)
- Rate ratio: 0.16 (95% CI 0.04-0.61, P<0.001)
- No apparent differences in secondary endpoints: appropriate ICD therapies, hospitalizations, NTproBNP levels
- No significant differences in predefined adverse and serious adverse events
HCN Medical Memo
ALthough these results are intriguing, the early termination and small sample size limit the study’s conclusions. Further research is needed to confirm the potential antiarrhythmic effects of SGLT2 inhibitors in heart failure patients. Clinicians should continue to follow current guidelines for SGLT2i use in heart failure management while staying informed about emerging evidence on their potential broader cardiovascular benefits.
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