Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
This study will provide insight into whether cardiac function changes with oral Ketone Esters (KE) administered to patients with Type 2 Diabetes Mellitus (T2DM) and Heart failure with reduced ejection fraction (HFrEF). Plasma ketones are avidly extracted by cardiac muscle and their uptake is not dependent upon insulin or influenced by insulin resistance.
• Subjects must be on a stable dose of guideline-directed medications for Heart Failure (HF).
• Patients will have an established diagnosis of HF before the screening visit, documented by an acceptable imaging modality in the last 6 months.
• Age = 18-80 y
• Body Mass Index (BMI) =23-38 kg/m2
• Glycated hemoglobin (HbA1c) = 6.0-10.0%
• Blood Pressure (BP) \< 145/85 mmHg
• Estimated Glomerular Filtration Rate (eGFR) \> 30 ml/min•1.73 m2
• For women of child-bearing age (WOCBA) willingness to use contraception, if applicable.