Ketone Pharmacokinetic Study in HFrEF

Phase 1

Completed

Interventions: Dietary Supplement: DeltaG (250 mg/kg)
Dietary Supplement: DeltaG (500 mg/kg)

Brief Summary: The purpose of this study is to test whether an over-the-counter ketone ester drink is well tolerated in people with heart failure on, and not on, a heart failure medication class called SGLT2 inhibitors. The research team is trying to determine the safest dose of Delta G. The study has a single visit. Participants will be served a light breakfast with the study drink, a physical exam will be conducted, and the study team will obtain information about demographics and medical history. The study team will draw blood intravenously up to eight times over the course of the half-day visit.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Intentional ketogenic (high fat, low carbohydrate) diet (must be off ketogenic diet for >7 days prior to visit)
Significant liver disease (cirrhosis) or alcohol abuse disorder (>14 drinks/week).
Unique cardiomyopathies: infiltrative/hypertrophic cardiomyopathy, pericardial disease, or other cardiomyopathies that in the investigator's opinion have unique treatment options that would be less likely to be affected by ketone therapy.
Estimated glomerular filtration rate<25 mL/min/1.73 m2 as the most recent value in the last year.
Type 1 diabetes mellitus
Use of ventricular assist device, history of heart transplant, or use of continuous inotropes
Pregnant women. Due to unknown affects of nutritional ketosis in pregnant women, pregnancy will be an exclusion. Accordingly, women of childbearing age with a menstrual cycle within the past year will be asked to submit a urine specimen for pregnancy testing.

Arm && Interventions

Group	Intervention	Description
250 mg/kg ketone ester	DeltaG (250 mg/kg)	The first 5 patients within each SGLT2i stratum will receive ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg.
500 mg/kg ketone ester	DeltaG (500 mg/kg)	The second 5 patients within each SGLT2i stratum will receive ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.

Primary Outcome Measures

Name	Time	Method
Venous pH Measured Via Peripheral Blood	1 hour	The pH scale ranges from 0 to 14, with 7 being neutral. Each number on the pH scale represents a ten-fold change in the acidity or basicity of a solution.
Glucose Level Measured Via Peripheral Blood	1 hour
Systolic Blood Pressure	1 hour	Taken by blood pressure cuff on the arm
Beta-hydroxybutyrate (BHB) Level Measured Via Peripheral Blood	1 hour	BHB is a chemical that is made by the body. It provides energy when not enough carbohydrates or sugars have been eaten.