Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
The clinical benefits of the dual Sodium-Glucose cotransporter (SGLT) 1 and 2-inhibition have
recently been reported in two clinical trials. The SOLOIST reported the benefits of
sotagliflozin in Type-2 Diabetes Mellitus (T2DM) patients hospitalized for worsening of Heart
Failure (HF), while the SCORED involved T2DM patients with Chronic Kidney Disease (CKD). It
is worth noting that not only did the event curves separate within the first week
post-treatment, but the effects of sotagliflozin on HF-related outcomes were observed
regardless of Left Ventricular Ejection Fraction (LVEF) values and did not seem to attenuate
with increasing LVEF as seen with empagliflozin and sacubitril/valsartan. Despite the
favorable outcomes, the mechanism(s) of action through which sotagliflozin exerts these
benefits remains unclear.
The present study aims to investigate the potential (non-glucose dependent) "cardio-renal"
pleiotropic effects of sotagliflozin in a mechanistic, randomized, double blind,
placebo-control trial in HF patients with preserved ejection fraction (HFpEF). Comparisons
between treatment groups will be made using cardiac MRI, CPET, 6-MWT and KCCQ-12.