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Completed

NCT Number: NCT05757193

Ketone Pharmacokinetic Study in HFrEF

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction Acid-Base Imbalance Acidosis Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DeltaG (250 mg/kg)

Dietary Supplement

250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate

DeltaG (500 mg/kg)

Dietary Supplement

500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate

Primary outcomes

  1. 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.

  2. Glucose Level Measured Via Peripheral Blood

    Time frame: 1 hour

  3. Systolic Blood Pressure

    Time frame: 1 hour

    Taken by blood pressure cuff on the arm

  4. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • American Heart Association
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Ketone Pharmacokinetic Study in Heart Failure With Reduced Ejection Fraction

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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