Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
| Condition | Heart Failure With Preserved Ejection Fraction |
|---|---|
| Phase | Phase 4 |
| Sponsor | Juan Badimon |
| Status | Completed |
| Enrollment | 88 participants |
| Interventions | Sotagliflozin |
| Start date | Oct 26, 2022 |
| Completion date | Jun 4, 2025 |
| Results posted | Jun 24, 2026 |
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.
Changes in Left Ventricular Mass in CMRI
| Sotagliflozin | -8.6 grams |
|---|---|
| Placebo | 5.7 grams |
Open in BENITIONS View on ClinicalTrials.gov
Other trials for this condition
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- Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant — University of Utah
- Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure — Yale University
- Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using th — Boston Children's Hospital
- PROACTIVE-HF IDE Trial Heart Failure NYHA Class III — Endotronix, Inc.
- Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coord — Weill Medical College of Cornell University