Ketone Pharmacokinetic Study in HFrEF

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

Ketone Pharmacokinetic Study in Heart Failure With Reduced Ejection Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05757193
• Other study ID #: Pro00111723
• Secondary ID: K23HL161348
• Status: Completed
• Phase: Phase 1
• Start date: June 2, 2023
• Est. completion date: January 11, 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Dietary Supplement:
• DeltaG (250 mg/kg)
250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
• DeltaG (500 mg/kg)
500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	American Heart Association, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous pH	Peripheral blood	1 hour
Primary	Glucose	Peripheral blood	1 hour
Primary	Systolic blood pressure	Taken by blood pressure cuff on the arm	1 hour
Primary	Beta-hydroxybutyrate level	Peripheral blood	1 hour