Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-04 @ 11:30 PM
Study NCT ID:
NCT04633460
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2020-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acute Effects of Exogenous Ketone Ester Administration in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C524675', 'term': 'formic acid 4-(3-oxobutyl)phenyl ester'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'payman.zamani@pennmedicine.upenn.edu', 'phone': '(215) 662-4000', 'title': 'Payman Zamani', 'organization': 'Hospital of the University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected the day of the study visit (the day of the first intervention visit, "Day 1", and the day of the second intervention visit, approximately "Day 8").', 'eventGroups': [{'id': 'EG000', 'title': 'Ketone Ester', 'description': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester\n\nKetone ester: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 7, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'KE-free solution\n\nplacebo drink: KE free placebo drink', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 6, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart racing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain with blood draw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Laryngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximal Exercise Capacity (Peak VO2) Assessed by Cardiopulmonary Exercise Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Ester', 'description': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester\n\nKetone ester: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'KE-free solution\n\nplacebo drink: KE free placebo drink'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed 60 minutes after the intervention.', 'description': 'Peak VO2', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 20 participants contributed to the data. 10 participants started first in the ketone ester group and then crossed over to placebo, while 10 participants started first in the placebo arm and crossed over the ketone ester.'}, {'type': 'PRIMARY', 'title': 'Submaximal Exercise Capacity (Exercise Time at 75% of Peak Workload) Assessed by Cardiopulmonary Exercise Testing.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Ester', 'description': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester\n\nKetone ester: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'KE-free solution\n\nplacebo drink: KE free placebo drink'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed 30 minutes after the intervention.', 'description': 'Exercise time at 75% of peak workload', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 20 participants contributed to the data. 10 participants started first in the ketone ester group and then crossed over to placebo, while 10 participants started first in the placebo arm and crossed over the ketone ester.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Systemic Vascular Resistance With Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Ester', 'description': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester\n\nKetone ester: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'KE-free solution\n\nplacebo drink: KE free placebo drink'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.5', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '-34.2', 'spread': '11.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed 60 minutes after the intervention.', 'description': 'Percent change in systemic vascular resistance with exercise', 'unitOfMeasure': 'Percent change from rest to peak exercis', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available data (13 in ketone ester group and 14 in the placebo group) shown here.'}, {'type': 'SECONDARY', 'title': 'Substrate Utilization (Reflected by the Respiratory Exchange Ratio) Assessed by Cardiopulmonary Exercise Testing.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Ester', 'description': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester\n\nKetone ester: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'KE-free solution\n\nplacebo drink: KE free placebo drink'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed 60 minutes after the intervention.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 20 participants contributed to the data. 10 participants started first in the ketone ester group and then crossed over to placebo, while 10 participants started first in the placebo arm and crossed over the ketone ester.'}, {'type': 'SECONDARY', 'title': 'VO2 Efficiency (Total Work Performed Over Oxygen Consumed) During Submaximal Cardiopulmonary Exercise Testing.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Ester', 'description': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester\n\nKetone ester: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'KE-free solution\n\nplacebo drink: KE free placebo drink'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed 60 minutes after the intervention.', 'unitOfMeasure': 'kJ/L O2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 20 participants contributed to the data. 10 participants started first in the ketone ester group and then crossed over to placebo, while 10 participants started first in the placebo arm and crossed over the ketone ester.'}, {'type': 'SECONDARY', 'title': 'Presence of Exercise-induced Arrhythmias (Significant Atrial or Ventricular Arrhythmias)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketone Ester', 'description': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester\n\nKetone ester: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'KE-free solution\n\nplacebo drink: KE free placebo drink'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed throughout the study visit date after the intervention is given (until leaving the research study center that day).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 20 participants contributed to the data. 10 participants started first in the ketone ester group and then crossed over to placebo, while 10 participants started first in the placebo arm and crossed over the ketone ester.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketone Ester First, Then Placebo', 'description': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester\n\nKetone ester: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis.\n\n10 individuals were randomized to acute dosing of KE first. Then, after approximately 7 day washout, these 10 individuals received acute dosing of placebo.'}, {'id': 'FG001', 'title': 'Placebo First, Then Ketone Ester', 'description': 'KE-free solution first, then KE after 7 day washout\n\nplacebo drink: KE free placebo drink\n\n10 individuals were randomized to acute dosing of placebo first. Then, after approximately 7 day washout, these 10 individuals received acute dosing of KE.'}], 'periods': [{'title': 'First Intervention', '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'}]}]}, {'title': 'Washout', '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'}]}]}, {'title': 'Second Intervention', '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'}]}]}], 'preAssignmentDetails': 'Out of 26 consented participants, 5 screen failed and 1 participant withdrew, leading to 20 randomized participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized First to Ketone Ester', 'description': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester\n\nKetone ester: A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis.\n\n10 individuals were randomized to ketone ester first, and 10 individuals were randomized to placebo first.'}, {'id': 'BG001', 'title': 'Randomized First to Placebo', 'description': 'KE-free solution\n\nplacebo drink: KE free placebo drink.\n\n10 individuals were randomized to ketone ester first, and 10 individuals were randomized to placebo first.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'spread': '7', 'groupId': 'BG000'}, {'value': '71', 'spread': '10', 'groupId': 'BG001'}, {'value': '71', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All 20 randomized participants are included.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-15', 'size': 351927, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-07T10:40', 'hasProtocol': True}, {'date': '2024-02-01', 'size': 86526, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-06T13:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Overview: The overall study design will be a randomized, double-blind crossover comparison of ketone ester (KE) therapy vs. KE-free vehicle in 20 patients with established HF with preserved ejection fraction (HFpEF). The main outcomes will be measures of exercise performance (peak and submaximal exercise).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2020-10-23', 'resultsFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2020-11-11', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-06', 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Exercise Capacity (Peak VO2) Assessed by Cardiopulmonary Exercise Testing', 'timeFrame': 'Assessed 60 minutes after the intervention.', 'description': 'Peak VO2'}, {'measure': 'Submaximal Exercise Capacity (Exercise Time at 75% of Peak Workload) Assessed by Cardiopulmonary Exercise Testing.', 'timeFrame': 'Assessed 30 minutes after the intervention.', 'description': 'Exercise time at 75% of peak workload'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Systemic Vascular Resistance With Exercise', 'timeFrame': 'Assessed 60 minutes after the intervention.', 'description': 'Percent change in systemic vascular resistance with exercise'}, {'measure': 'Substrate Utilization (Reflected by the Respiratory Exchange Ratio) Assessed by Cardiopulmonary Exercise Testing.', 'timeFrame': 'Assessed 60 minutes after the intervention.'}, {'measure': 'VO2 Efficiency (Total Work Performed Over Oxygen Consumed) During Submaximal Cardiopulmonary Exercise Testing.', 'timeFrame': 'Assessed 60 minutes after the intervention.'}, {'measure': 'Presence of Exercise-induced Arrhythmias (Significant Atrial or Ventricular Arrhythmias)', 'timeFrame': 'Assessed throughout the study visit date after the intervention is given (until leaving the research study center that day).'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '40243975', 'type': 'DERIVED', 'citation': 'Selvaraj S, Karaj A, Chirinos JA, Denney N, Grosso G, Fernando M, Chambers K, Demastus C, Reddy R, Langham M, Kumar D, Maynard H, Pourmussa B, Prenner SB, Cohen JB, Ischiropoulos H, Rickels MR, Poole DC, Church DD, Wolfe RR, Kelly DP, Putt M, Margulies KB, Zamani P. Crossover Trial of Exogenous Ketones on Cardiometabolic Endpoints in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2025 Dec;13(12):102435. doi: 10.1016/j.jchf.2025.03.002. Epub 2025 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether a ketone ester drink will improve exercise in people with heart failure (HF) compared to a placebo. In HF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. There may be several reasons why these symptoms occur.\n\nThere is some evidence that in addition to problems with the heart, patients with HF also have problems with their arteries and muscles that affect their ability to exercise. Ketones have been shown to improve exercise capacity in healthy volunteers, which may be related to effects on the heart function or on muscles. An infusion of ketones through an intravenous (IV) line has also been shown to significantly improve heart function, but whether a drink can produce similar improvements in HF patients is not known. This drink has been given status by Food and Drug Administration as "generally regarded as safe".\n\nThe use of DeltaG in this study is experimental. DeltaG has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.', 'detailedDescription': 'This is a randomized, crossover trial of ketone ester versus placebo in 20 patients with heart failure with preserved ejection fraction. Participants come for a baseline assessment. If they meet eligibility criteria, they are randomized to receive ketone ester first or placebo first. After approximately a week washout period, participants return for the last visit to receive the product they did not receive at the previous visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Left ventricular ejection fraction ≥ 50%\n2. Evidence for elevated filling pressures as follows (at least one of the following between a-d):\n\n a. Mitral early (E)/mitral septal tissue annular (e') velocity ratio \\> 8 in addition to one of the following: i. Large left atrium (LA\\>4.0 cm width or LA volume index \\>34 mL/m2) ii. Chronic loop diuretic use for control of symptoms iii. Elevated natriuretic peptides within the past year (NT-proBNP\\>125 pg/ml or BNP\\>35 pg/ml) b. Mitral E/e' ratio \\> 14 at rest or with exercise c. Elevated invasively-determined filling pressures previously (resting left ventricular end-diastolic pressure \\>16 mm Hg or pulmonary capillary wedge pressure \\> 15 mmHg; or PCWP/LVEDP ≥ 25 mmHg with exercise) d. Prior episode of acute heart failure requiring IV diuretics with evidence of volume overload on exam/radiology or elevated natriuretic peptides.\n\nExclusion Criteria\n\n1. Intentional ketogenic (high fat, low carbohydrate) diet in the last week or use of ketogenic medications (SGLT2 inhibitors)\n2. Significant liver disease (liver function tests \\> 3x upper limit of normal, cirrhosis) or alcohol abuse disorder (\\>14 drinks/week).\n3. Contraindications to stress testing, conditions that limit exercise, and other clinically-significant causes of exertional limitation (claudication with peripheral artery disease, atrial fibrillation and heart rate \\>110 at rest, systolic blood pressure\\>180 mmHg or diastolic blood pressure\\>110 mmHg, infiltrative/hypertrophic/inflammatory cardiomyopathy, clinically significant pericardial disease, joint or neuromuscular disease that precludes exercise, acute coronary syndrome within the last 2 months, estimated glomerular filtration rate\\<30 mL/min/1.73 m2, and hemoglobin \\< 9 mg/dL).\n4. Clinically significant lung disease. This would be defined by severe obstructive lung disease (Gold stage 3), a requirement for supplemental oxygen, or chronic obstructive pulmonary disease with an exacerbation requiring steroids or antibiotics within the last 2 months.\n5. \\>= Moderate aortic stenosis, \\>mild mitral stenosis, \\>= moderate aortic or mitral regurgitation on screening echocardiogram\n6. Type 1 diabetes mellitus\n7. 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.\n8. Angina due to epicardial coronary disease or known presence of clinically-significant, unrevascularized epicardial coronary disease, in the investigator's opinion.\n9. Prior reduced LVEF to \\< 45%"}, 'identificationModule': {'nctId': 'NCT04633460', 'briefTitle': 'Acute Effects of Exogenous Ketone Ester Administration in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Acute Effects of Exogenous Ketone Ester Administration in Heart Failure', 'orgStudyIdInfo': {'id': '833870'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketone ester', 'description': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester', 'interventionNames': ['Dietary Supplement: Ketone ester']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'KE-free solution', 'interventionNames': ['Dietary Supplement: placebo drink']}], 'interventions': [{'name': 'Ketone ester', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis', 'armGroupLabels': ['Ketone ester']}, {'name': 'placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'KE free placebo drink', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Presbyterian Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Kenneth B Margulies', 'investigatorAffiliation': 'University of Pennsylvania'}}}}