Summary: In a single-centre, open-label randomised trial of 70 patients with type 2 diabetes and heart failure with preserved ejection fraction (HFpEF), empagliflozin 10 mg daily for 6 months improved the primary endpoint of 6-minute walk distance and lowered left ventricular filling pressure (E/e’ at rest and during exercise) versus usual care. Improvements in diastolic, atrial reservoir, contractile and chronotropic reserve and in NT-proBNP and sST2 were also reported (all P<0.05), though exact effect sizes were not provided in the abstract.
PICO Summary
| Element | Detail |
|---|---|
| Population | 70 adults with type 2 diabetes and stable HFpEF (NYHA II-III, LVEF >=50%, raised LV filling pressure at rest and/or on exercise); single-centre, Russia. Open-label RCT (NCT03753087). |
| Intervention | Empagliflozin 10 mg once daily for 6 months (n=35), added to usual care. |
| Comparison | Usual care without empagliflozin (control, n=35); open-label, no placebo. |
| Outcome | Primary endpoint (change in 6-minute walk distance) increased significantly vs control (P<0.05). Secondary: left atrial volume index and E/e' at rest and on exercise decreased; LV diastolic, LA reservoir, contractile and chronotropic reserves improved; NT-proBNP and sST2 fell (all P<0.05). Exact mean changes, 95% CIs and precise p-values were not reported in the abstract; no ARR/NNT (no clinical-event endpoints). Safety/adverse events were not reported in the abstract. |
Empagliflozin in diabetic HFpEF
Open-label RCT · T2DM + HFpEF · 6 months
Over 6 months, add-on empagliflozin improved 6-minute walk distance and lowered LV filling pressure versus usual care in diabetic HFpEF. Open-label, single-centre and unblinded, with no published effect sizes, so the result is mechanistic and hypothesis-generating.
Expert Commentary
This is a small, single-centre, open-label mechanistic trial, and it should be read as hypothesis-generating rather than confirmatory. Within those limits the signal is coherent: empagliflozin improved the primary functional endpoint (6-minute walk distance) and was accompanied by lower estimated filling pressures and better diastolic, atrial and chronotropic reserve, alongside falls in NT-proBNP and sST2. These findings are mechanistically plausible and dovetail with the outcome benefit already established for SGLT2 inhibitors in larger HFpEF trials, lending physiological texture to why those drugs work. The principal limitation is the open-label design with no placebo arm, which leaves the effort-dependent 6-minute walk distance vulnerable to performance and expectation bias; only 70 patients were studied at one site, and the abstract reports significance as P<0.05 without effect sizes, confidence intervals or a safety analysis, so the magnitude and tolerability cannot be judged from these data. Can I use this with my patients? Not as a reason to start empagliflozin, since the indication in a patient with type 2 diabetes and HFpEF already rests on robust outcome trials; this study is better used to explain the likely mechanism. A larger blinded trial with reported effect estimates and adverse events would be welcome to confirm the reserve findings.
References
Ovchinnikov A, Potekhina A, Filatova A, Svirida O, Zherebchikova K, Ageev F, Belyavskiy E. Effects of empagliflozin on functional capacity, LV filling pressure, and cardiac reserves in patients with type 2 diabetes mellitus and heart failure with preserved ejection fraction: a randomized controlled open-label trial. Cardiovasc Diabetol. 2025;24(1):196. doi:10.1186/s12933-025-02756-y