Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients

Inclusion criteria

patients should meet all of the following criteria

• Ambulatory patients age ≥ 18 years
• Written informed consent prior to admission to the trial.
• No diabetes as confirmed by HbA1c <6.5%, fasting serum glucose <126 mg/dL, and review of concomitant medications and medical history
• Diagnosis of Heart failure (NYHA II to III)
• LVEF > 50%
• On medical therapy for heart failure consistent with prevailing cardiovascular guidelines at a stable dose for ≥4 weeks prior to screening, except for diuretics which must have been stable for ≥2 weeks prior to screening
• Women of child-bearing potential must agree to use birth control measures with a failure rate of <1% per year during the treatment period of the study

Exclusion criteria

• Type 1 and Type 2 diabetes
• Acute coronary syndrome (ACS) or cardiac surgery within the last week.
• Pregnant or lactating women,
• Acute decompensated HF or hospitalized for HF within 1 month from screening visit
• Glomerular Filtration Rate (GFR) < 25 ml/ min/1.73m2,
• Patients on drugs with potential interaction with sotagliflozin including digoxin, phenytoin, HIV medication and rifampin.
• Receiving SGLT2-I 3-months prior to randomization.
• non-MRI compatible PM or ICD and any other medical or physical condition considered unappropriated by a study physician.