Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 7:58 AM
Study NCT ID:
NCT05348460
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled cross-over design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise', 'timeFrame': 'During study-visit', 'description': 'Rate and magnitude of change in PCr and Pi concentrations from baseline to maximum exercise.'}], 'secondaryOutcomes': [{'measure': 'Rate and magnitude of change in PCr and Pi concentrations during recovery', 'timeFrame': 'During study visit', 'description': 'Rate and magnitude of change in PCr and Pi concentrations during recovery of change in PCr and Pi is expressed as change in Pi/PCr (ΔPi/PCr)'}, {'measure': 'Intramuscular pH', 'timeFrame': 'During study visit', 'description': 'Rates and magnitude of change in intramuscular pH during exercise and recovery'}, {'measure': 'Maximal exercise performance', 'timeFrame': 'During study visit', 'description': 'Maximal exercise performance'}, {'measure': 'Change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise', 'timeFrame': 'During study visit', 'description': 'Change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Ketone Body', 'HFrEF', 'Skeletal Muscle Metabolism', 'Mitochondrial Ketone Oxidation', '31P MRS', 'Pi/Pcr'], 'conditions': ['Heart Failure With Reduced Ejection Fraction', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31phosphorus Magnetic Resonance Spectroscopy (31P MRS) exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.', 'detailedDescription': 'The goal of this study is to investigate if oral ketone supplementation stimulates mitochondrial ATP production and improves exercise performance in patients with chronic HF. In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment. Endpoints include rate and magnitude of change in phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise, rate and magnitude of change in PCr and Pi concentrations during recovery, rates and magnitude of change in intramuscular pH during exercise and recovery, maximal exercise performance and change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Heart Failure NYHA II - III\n* LVEF ≤40%\n* Stable for the last 1 month prior to the study\n\nExclusion Criteria:\n\n* Age \\<18 years;\n* Unable or unwilling to undergo exercise MRI (physical disabilities, claustrophobia);\n* Unable to complete the exercise protocol during the screening visit according to the professional opinion of the investigators;\n* Comorbidities which can influence study results such as muscular dystrophies, peripheral artery disease, diabetes mellitus, severe anaemia (defined as Hb ≤6 mmol/L);\n* Pregnant/trying to get pregnant/breastfeeding during the period from the first exercise test until 4 weeks after the last exercise test);\n* Absolute contra-indications to undergo MRI according to the current UMCG protocols and guidelines (e.g. non-conditional medical device, recent device implantation, incompatible ferromagnetic objects in the body).\n* BMI \\< 16 kg/m2; BMI \\> 35 kg/m2\n* Unable to understand study procedures;\n* Unable or unwilling to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05348460', 'acronym': 'KETONE-HF', 'briefTitle': 'Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure', 'orgStudyIdInfo': {'id': '201900710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ketone - Placebo treatment', 'description': 'Patients will first receive a supplemental drink containing a ketone ester before performing the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time after receiving the placebo treatment.', 'interventionNames': ['Dietary Supplement: Ketone ester drink (DeltaG®, 500 mg/kg body weight)', 'Dietary Supplement: Taste-matched, isovolumic placebo drink']}, {'type': 'OTHER', 'label': 'Placebo - Ketone treatment', 'description': 'Patients will first receive a placebodrink before performing the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time after receiving the supplemental drink containing a ketone ester.', 'interventionNames': ['Dietary Supplement: Ketone ester drink (DeltaG®, 500 mg/kg body weight)', 'Dietary Supplement: Taste-matched, isovolumic placebo drink']}], 'interventions': [{'name': 'Ketone ester drink (DeltaG®, 500 mg/kg body weight)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'In a double blind fashion, subjects will receive a ketone ester drink ór a taste-matched, isovolumic placebo drink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.', 'armGroupLabels': ['Ketone - Placebo treatment', 'Placebo - Ketone treatment']}, {'name': 'Taste-matched, isovolumic placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'In a double blind fashion, subjects will receive a ketone ester drink ór a taste-matched, isovolumic placebo drink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.', 'armGroupLabels': ['Ketone - Placebo treatment', 'Placebo - Ketone treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Daan Westenbrink, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unversity Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Netherlands Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}