Effects of Acute and Chronic Ketone Ester Consumption on Exercise Tolerance and Cardiac Function in Subjects With the Metabolic Phenotype of Heart Failure With Preserved Ejection Fraction
This study is being done to evaluate how a ketone ester (KE) beverage affects heart function and health in people with heart failure compared to a placebo beverage (a beverage made with standard food ingredients that do not contain ketone esters).
• Age ≥ 18 years old and ≤ 80 years old
• NYHA class I - III for at least 3 months
• Ejection fraction ≥ 50% by biplane 2D echo, 3D echo, or CMR.
• Echo findings of abnormal of indeterminant diastolic function or Right right heart catheterization (RHC) data: At rest: mean pulmonary capillary wedge pressure (PCWP) \> 15 mmHg. pulmonary vascular resistance (PVR) \< 3 Wood Units
• Stable medical therapy for at least 3 months as determined by the treating physician (no new cardiac or diabetic medications within 3 months of enrollment, or during enrollment) and dosage should be stable for 1 month prior to enrollment). Dose down titration and discontinuation is allowed during the study
• Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization
• Body Mass Index (BMI) ≥ 25 and ≤ 50 or Type II Diabetes Mellitus or prediabetes as defined by fasting glucose of 100 - 125 mg/dL or glycated hemoglobin (A1C) 5.7-6.4%, or metabolic syndrome
• a. To meet definition of metabolic syndrome (NCEP ATPIII), 3 of the following criteria must be met: i. Abdominal obesity, defined as a waist circumference ≥102 cm (40 in) in men and ≥88 cm (35 in) in females ii. Serum triglycerides ≥150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides iii. Serum high-density lipoprotein (HDL) cholesterol \<40 mg/dL (1 mmol/L) in males and \<50 mg/dL (1.3 mmol/L) in females or drug treatment for low HDL cholesterol iv. Blood pressure ≥130/85 mmHg or drug treatment for elevated blood pressure v. Fasting plasma glucose (FPG) ≥100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose
• Ability to participate in exercise treadmill testing
• Ability to sign written consent