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Ketone Pharmacokinetic Study in HFrEF

NCT ID: NCT05757193

Last Updated: 2024-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-02

Study Completion Date

2024-01-11

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure With Reduced Ejection Fraction

Keywords

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DeltaG ketone ester metabolites metabolomics ketoacidosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants stratified based on use of background use of SGLT2 inhibitors
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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250 mg/kg ketone ester

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

Group Type EXPERIMENTAL

DeltaG (250 mg/kg)

Intervention Type DIETARY_SUPPLEMENT

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

500 mg/kg ketone ester

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

Group Type EXPERIMENTAL

DeltaG (500 mg/kg)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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DeltaG (250 mg/kg)

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

Intervention Type DIETARY_SUPPLEMENT

DeltaG (500 mg/kg)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

American Heart Association

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Senthil Selvaraj, MD, MSTR, MA

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Selvaraj S, Kwee LC, Thompson EJ, He M, Hornik CP, Devore AD, Patel CB, Mentz RJ, Fudim M, Taylor L, Milosovic S, Hurdle M, Cade WT, Ilkayeva O, Muehlbauer MJ, Newgard CB, Kelly DP, Zamani P, Margulies KB, Shah SH. Metabolic and Pharmacokinetic Profiling of a Ketone Ester by Background SGLT2 Inhibitor Therapy in HFrEF. JACC Basic Transl Sci. 2025 Mar;10(3):290-303. doi: 10.1016/j.jacbts.2024.10.014. Epub 2024 Nov 15.

Reference Type DERIVED
PMID: 40139871 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K23HL161348

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00111723

Identifier Type: -

Identifier Source: org_study_id