Abstract Body (Do not enter title and authors here): SGLT2i are the first pharmacological class shown to reduce hospitalization and cardiovascular (CV) mortality in Heart Failure (HF) patients. Two major trials (SOLOIST and SCORED) have shown the CV benefits of Sotagliflozin, a dual SGLT1/2 inhibitor, in diabetic HF patients. However, sotagliflozin trials have not included HF patients without diabetes. We now report results from the SOTA-P-CARDIA trial (NCT05562063); a prospective, randomized, double-blind, placebo-controlled study evaluating the effects of sotagliflozin in non-diabetic HFpEF patients.

Qualifying patients were randomized in blocks of 4, to either sotagliflozin or placebo for a 6-months period. The primary endpoint was changes in left ventricular mass (LVMass) by CMR from baseline to end-of-study between the groups. Secondary endpoints included changes in cardiac function and structure, peak VO2, 6-MWT and quality of life. A total of 88 patients were randomized. Demographics of the study population and major results are presented in Tables and Figure below.
The administration of 6-months of sotagliflozin to non-diabetic HFpEF patients resulted in significant improvements in LVMass, diastolic function, 6-MWT and Quality of Life as compared to placebo. Additionally, Peak VO2 improved in the sotagliflozin group, but without reaching statistical significance. In conclusion, our data support the potential use of sotagliflozin in the management of HFpEF patients without diabetes, expanding the therapeutic benefit of dual SGLT1/2 inhibition beyond the diabetic population.