Effect of ertugliflozin on left ventricular function in type 2 diabetes and pre-heart failure: the Ertu-GLS randomized clinical trial
Authors' conclusion
This study demonstrated that ertugliflozin has beneficial effects on left ventricular function in individuals with type 2 diabetes and pre-heart failure, and it provided insights into potential underlying mechanisms.
Study context
- Population
- Individuals with T2D inadequately controlled with antidiabetic medications and pre-heart failure (left ventricular hypertrophy, E/e' >15, or impaired left ventricular global longitudinal strain (LVGLS)); mean age 63.9 ± 9.2 years; 38% womenrandomized 1:1
- Participants
- 102 individuals
- Comparison
- Ertugliflozin 5 mg once daily vs placebo
- Primary endpoint
- Change in left ventricular global longitudinal strain (LVGLS)
- Follow-up
- 24 weeks
Methodological detailsdouble-blind, placebo-controlled, 24-week
- Double-blind
- Placebo-controlled
- 24-week
Primary result
As reported in the abstract
LVGLS, baseline to 24 weeks
- Ertugliflozin: LVGLS from - 15.5 ± 3.1% to - 16.6 ± 2.8%
- P = 0.004
- Placebo: LVGLS from - 16.7 ± 2.7% to - 16.4 ± 2.6%
- P = 0.509
Secondary outcomes
Left ventricular mass index (LVMI) and left ventricular ejection fraction (LVEF)
- Improvements in LVMI and LVEF were also observed
Metabolic and other markers
- Significant reductions in HbA1c, systolic blood pressure, whole-body and visceral fat, uric acid, proteinuria, NT-proBNP and lipoprotein(a)
ACE2 and angiotensin (1-7) levels (prespecified exploratory)
- Correlation of ACE2 change with LVGLS change
- r = 0.456, P < 0.001
- Correlation of angiotensin (1-7) change with LVGLS change
- r = 0.541, P < 0.001
- Significantly increased with ertugliflozin vs placebo
Safety
- Adverse events were similar between the two groups
Original publication
Effect of ertugliflozin on left ventricular function in type 2 diabetes and pre-heart failure: the Ertu-GLS randomized clinical trial. Cardiovasc Diabetol. Published 22 October 2024. doi:10. 1186/ s12933-024-02463-0
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