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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL161348 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 250 mg/kg ketone ester | Experimental | The first 5 patients within each SGLT2i stratum will receive ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. |
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| 500 mg/kg ketone ester | Experimental | The second 5 patients within each SGLT2i stratum will receive ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DeltaG (250 mg/kg) | Dietary Supplement | 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate |
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| Measure | Description | Time Frame |
|---|---|---|
| Venous pH Measured Via Peripheral Blood | 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. | 1 hour |
| Glucose Level Measured Via Peripheral Blood | 1 hour | |
| Systolic Blood Pressure | Taken by blood pressure cuff on the arm | 1 hour |
| Beta-hydroxybutyrate (BHB) Level Measured Via Peripheral Blood | BHB is a chemical that is made by the body. It provides energy when not enough carbohydrates or sugars have been eaten. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senthil Selvaraj, MD, MSTR, MA | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40139871 | Derived | 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. |
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Participants were recruited within the Duke University Health System.
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| ID | Title | Description |
|---|---|---|
| FG000 | 250 mg/kg Ketone Ester | Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. DeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate |
| FG001 | 500 mg/kg Ketone Ester | Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg. DeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 250 mg/kg Ketone Ester | Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. DeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate |
| BG001 | 500 mg/kg Ketone Ester |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Venous pH Measured Via Peripheral Blood | 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. | Posted | Mean | Standard Deviation | unitless | 1 hour |
|
Reported prior to the end of the study visit, up to 4 hours after ketone ester ingestion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 250 mg/kg Ketone Ester | Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg. DeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senthil Selvaraj, MD | Duke University | 919-660-0730 | Senthil.Selvaraj@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2023 | Dec 3, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 22, 2023 | Jan 12, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants stratified based on use of background use of SGLT2 inhibitors
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| DeltaG (500 mg/kg) | Dietary Supplement | 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate |
|
Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.
DeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Glucose Level Measured Via Peripheral Blood | Posted | Mean | Standard Deviation | mg/dL | 1 hour |
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| Primary | Systolic Blood Pressure | Taken by blood pressure cuff on the arm | Posted | Mean | Standard Deviation | mmHg | 1 hour |
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| Primary | Beta-hydroxybutyrate (BHB) Level Measured Via Peripheral Blood | BHB is a chemical that is made by the body. It provides energy when not enough carbohydrates or sugars have been eaten. | Posted | Mean | Standard Deviation | millimolar | 1 hour |
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| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | 500 mg/kg Ketone Ester | Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg. DeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate | 0 | 10 | 0 | 10 | 1 | 10 |
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