Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
Age: 18 years - 66+
Healthy Subjects: No
Study Phase: Phase 4
Recruitment Status: Recruiting
Start Date: October 26, 2022
End Date: June 01, 2024
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
- 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.
- Heart Failure