Ketone Pharmacokinetic Study in Heart Failure With Reduced Ejection Fraction
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Venous pH Measured Via Peripheral Blood
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of HFrEF (ejection fraction<=45%)
- •Systolic blood pressure greater >=90 mmHg
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.
Outcomes
Primary Outcomes
Venous pH Measured Via Peripheral Blood
Time Frame: 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
Time Frame: 1 hour
Systolic Blood Pressure
Time Frame: 1 hour
Taken by blood pressure cuff on the arm
Beta-hydroxybutyrate (BHB) Level Measured Via Peripheral Blood
Time Frame: 1 hour
BHB is a chemical that is made by the body. It provides energy when not enough carbohydrates or sugars have been eaten.
Secondary Outcomes
No secondary outcomes reported