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Ketone Pharmacokinetic Study in HFrEF

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DeltaG
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure With Reduced Ejection Fraction focused on measuring DeltaG, ketone ester, metabolites, metabolomics, ketoacidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketone ester

Arm Description

All patients will receive ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate. This will begin at 250 mg/kg once with dose escalation to 500 mg/kg in subsequent participants if all safety endpoints are achieved among 5 consecutive participants.

Outcomes

Primary Outcome Measures

Venous pH
Peripheral blood
Glucose
Peripheral blood
Systolic blood pressure
Taken by blood pressure cuff on the arm
Beta-hydroxybutyrate level
Peripheral blood

Secondary Outcome Measures

Full Information

First Posted
February 24, 2023
Last Updated
June 5, 2023
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT05757193
Brief Title
Ketone Pharmacokinetic Study in HFrEF
Official Title
Ketone Pharmacokinetic Study in Heart Failure With Reduced Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
DeltaG, ketone ester, metabolites, metabolomics, ketoacidosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Participants stratified based on use of background use of SGLT2 inhibitors
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketone ester
Arm Type
Experimental
Arm Description
All patients will receive ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate. This will begin at 250 mg/kg once with dose escalation to 500 mg/kg in subsequent participants if all safety endpoints are achieved among 5 consecutive participants.
Intervention Type
Dietary Supplement
Intervention Name(s)
DeltaG
Intervention Description
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Primary Outcome Measure Information:
Title
Venous pH
Description
Peripheral blood
Time Frame
1 hour
Title
Glucose
Description
Peripheral blood
Time Frame
1 hour
Title
Systolic blood pressure
Description
Taken by blood pressure cuff on the arm
Time Frame
1 hour
Title
Beta-hydroxybutyrate level
Description
Peripheral blood
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lacey Taylor
Phone
919-668-7184
Email
lacey.taylor@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senthil Selvaraj, MD, MSTR, MA
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lacey Taylor
Phone
919-668-7184
Email
lacey.taylor@duke.edu
First Name & Middle Initial & Last Name & Degree
Senthil Selvaraj, MD, MSTR, MA

12. IPD Sharing Statement

Plan to Share IPD
No

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Ketone Pharmacokinetic Study in HFrEF

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