Slide 1: SOTA-P-CARDIA (NCT 05562063): A RCT of Sotagliflozin in HFpEF patients without diabetes
SOTA-—P-—CARDIA (NCT 05562063) A RCT of Sotagliflozin in HFpEF patients without diabetes Baseline Final Visit =f ala = ~ - =| © =I! 9 an —S os el i—Ojy 6 min —Ojy 6min <4 ou ee Heart
Slide 2: Protocol Summary
Protocol Summary Title: Sotagliflozin in HFpEF patients without diabetes Description: Phase IV clinical trial of Sotagliflozin in the treatment of HFpEF patients without diabetes (investigator-initiated study). Study Design: Randomized, double-blinded, trial with Sotagliflozin vs Placebo for a perio
Slide 3: Enrollment and Disposition of Participants
| Enrollment HFpEF patients assessed for elegibility, n=375 Excluded (n = 287) + Not meeting inclusion criteria (n =274) + Declined to participate (n =9) + Other reasons (n = 4) Randomized (n = 88) Allocated to sotagliflozin (n =44) —— a + Received allocated intervention (n + Received allocated inte
Slide 4: Baseline Characteristics
Baseline Characteristics All Placebo Sotagliflozin p Value Total 88 (100%) 44 44 Demographic Female 62 (70.5%) 31 (70.5%) 31 (70.5%) 1.000 High diversity by Age including vulnerable and Mean, years 76.4496 76.0284 768+109 0.684 underrepresented groups 265 years 77 (87.5%) 39 (88.6%) 38 (86.4%) 0.747
Slide 5: Concomitant Medications
Concomitant Medications All Total 88 (100%) Medications B-blockers 64 (72.7%) MRA 15 (17.0%) ACE inhibitors/ARB 57 (64.8%) ARNi 14 (15.9%) Ca-antagonists 44 (50.0%) Statins 68 (77.3%) Diuretics 49 (55.7%) Amiodarone T (8.0%) Aspinn 37 (42.0%) Blood thinners 40 (45.5%) Corticoids 2 (2.3%) TABLE 2. Me
Slide 6: Effect on LV Mass (Primary Endpoint)
Effect on LV Mass (Primary Endpoint) LV mass @ Placebo "TT Di Sotagliflozin @ Treatment effect (p<0.001)
Slide 7: Effect on markers of LV filling pressures
Effect on markers of LV filling pressures Average E/e' ratio LA max ee i iH : ee i | i" _ a) Heart
Slide 8: Effect on 6MWT and Quality of Life
Effect on 6MWT and Quality of Life 6-MWT KCCQ-12 Absolute & from bi 8 forcmr
Slide 9: Summary of Major Findings
| /am Summary of Major Findings
Slide 10: Summary of Cardiometabolic Parameters
Summary of Cardiometabolic Parameters
Slide 11: Conclusions
Conclusions Sotagliflozin is associated with significant improvements in cardiac structure and function alongside symptoms and markers of congestion as well as quality of life and functional capacity in non-diabetic patients with HFpEF. Mount Sinai Heart