Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT05757193
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2023-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ketone Pharmacokinetic Study in HFrEF
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Senthil.Selvaraj@duke.edu', 'phone': '919-660-0730', 'title': 'Senthil Selvaraj, MD', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Reported prior to the end of the study visit, up to 4 hours after ketone ester ingestion.', 'eventGroups': [{'id': 'EG000', 'title': '250 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg.\n\nDeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '500 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.\n\nDeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Venous pH Measured Via Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg.\n\nDeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'id': 'OG001', 'title': '500 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.\n\nDeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}], 'classes': [{'categories': [{'measurements': [{'value': '7.30', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '7.28', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': '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.', 'unitOfMeasure': 'unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Glucose Level Measured Via Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg.\n\nDeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'id': 'OG001', 'title': '500 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.\n\nDeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'spread': '70', 'groupId': 'OG000'}, {'value': '101', 'spread': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg.\n\nDeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'id': 'OG001', 'title': '500 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.\n\nDeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'spread': '12', 'groupId': 'OG000'}, {'value': '110', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'Taken by blood pressure cuff on the arm', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Beta-hydroxybutyrate (BHB) Level Measured Via Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg.\n\nDeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'id': 'OG001', 'title': '500 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.\n\nDeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}], 'classes': [{'categories': [{'measurements': [{'value': '1.88', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'BHB is a chemical that is made by the body. It provides energy when not enough carbohydrates or sugars have been eaten.', 'unitOfMeasure': 'millimolar', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '250 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg.\n\nDeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'id': 'FG001', 'title': '500 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.\n\nDeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited within the Duke University Health System.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '250 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg.\n\nDeltaG (250 mg/kg): 250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'id': 'BG001', 'title': '500 mg/kg Ketone Ester', 'description': 'Participants received ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.\n\nDeltaG (500 mg/kg): 500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '8.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-24', 'size': 389925, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-03T08:44', 'hasProtocol': True}, {'date': '2023-12-22', 'size': 292365, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-12T09:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants stratified based on use of background use of SGLT2 inhibitors'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-02-24', 'resultsFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-03', 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous pH Measured Via Peripheral Blood', 'timeFrame': '1 hour', 'description': '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.'}, {'measure': 'Glucose Level Measured Via Peripheral Blood', 'timeFrame': '1 hour'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '1 hour', 'description': 'Taken by blood pressure cuff on the arm'}, {'measure': 'Beta-hydroxybutyrate (BHB) Level Measured Via Peripheral Blood', 'timeFrame': '1 hour', 'description': 'BHB is a chemical that is made by the body. It provides energy when not enough carbohydrates or sugars have been eaten.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DeltaG', 'ketone ester', 'metabolites', 'metabolomics', 'ketoacidosis'], 'conditions': ['Heart Failure With Reduced Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '40139871', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of HFrEF (ejection fraction\\<=45%)\n* Systolic blood pressure greater \\>=90 mmHg\n\nExclusion Criteria:\n\n* Intentional ketogenic (high fat, low carbohydrate) diet (must be off ketogenic diet for \\>7 days prior to visit)\n* Significant liver disease (cirrhosis) or alcohol abuse disorder (\\>14 drinks/week).\n* 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.\n* Estimated glomerular filtration rate\\<25 mL/min/1.73 m2 as the most recent value in the last year.\n* Type 1 diabetes mellitus\n* Use of ventricular assist device, history of heart transplant, or use of continuous inotropes\n* 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."}, 'identificationModule': {'nctId': 'NCT05757193', 'briefTitle': 'Ketone Pharmacokinetic Study in HFrEF', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Ketone Pharmacokinetic Study in Heart Failure With Reduced Ejection Fraction', 'orgStudyIdInfo': {'id': 'Pro00111723'}, 'secondaryIdInfos': [{'id': 'K23HL161348', 'link': 'https://reporter.nih.gov/quickSearch/K23HL161348', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '250 mg/kg ketone ester', 'description': 'The first 5 patients within each SGLT2i stratum will receive ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg.', 'interventionNames': ['Dietary Supplement: DeltaG (250 mg/kg)']}, {'type': 'EXPERIMENTAL', 'label': '500 mg/kg ketone ester', 'description': 'The second 5 patients within each SGLT2i stratum will receive ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.', 'interventionNames': ['Dietary Supplement: DeltaG (500 mg/kg)']}], 'interventions': [{'name': 'DeltaG (250 mg/kg)', 'type': 'DIETARY_SUPPLEMENT', 'description': '250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate', 'armGroupLabels': ['250 mg/kg ketone ester']}, {'name': 'DeltaG (500 mg/kg)', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate', 'armGroupLabels': ['500 mg/kg ketone ester']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Senthil Selvaraj, MD, MSTR, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}