Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 4:13 AM
Study NCT ID:
NCT04921293
Status:
UNKNOWN
Last Update Posted:
2022-10-18
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Endogenous and Exogenous Ketosis in Patients With Non-ischemic Chronic Heart Failure With Reduced Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ejection fraction Improvement', 'timeFrame': '10 days', 'description': 'Estimated by cardiac MRI'}], 'secondaryOutcomes': [{'measure': 'Clinical severity', 'timeFrame': '10 days', 'description': 'Estimated with the NYHA classification'}, {'measure': 'Liquid retention', 'timeFrame': '10 days', 'description': 'Estimated by electric bioimpedance'}, {'measure': 'Blood biomarker', 'timeFrame': '10 days', 'description': 'BNP'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endogenous ketosis', 'Exogenous ketosis', 'Heart failure'], 'conditions': ['Heart Failure With Reduced Ejection Fraction', 'Ketosis']}, 'referencesModule': {'references': [{'pmid': '32562735', 'type': 'BACKGROUND', 'citation': 'Astrup A, Magkos F, Bier DM, Brenna JT, de Oliveira Otto MC, Hill JO, King JC, Mente A, Ordovas JM, Volek JS, Yusuf S, Krauss RM. Saturated Fats and Health: A Reassessment and Proposal for Food-Based Recommendations: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Aug 18;76(7):844-857. doi: 10.1016/j.jacc.2020.05.077. Epub 2020 Jun 17.'}, {'pmid': '31231311', 'type': 'BACKGROUND', 'citation': 'Athinarayanan SJ, Adams RN, Hallberg SJ, McKenzie AL, Bhanpuri NH, Campbell WW, Volek JS, Phinney SD, McCarter JP. Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial. Front Endocrinol (Lausanne). 2019 Jun 5;10:348. doi: 10.3389/fendo.2019.00348. eCollection 2019.'}, {'pmid': '26819376', 'type': 'BACKGROUND', 'citation': 'Aubert G, Martin OJ, Horton JL, Lai L, Vega RB, Leone TC, Koves T, Gardell SJ, Kruger M, Hoppel CL, Lewandowski ED, Crawford PA, Muoio DM, Kelly DP. The Failing Heart Relies on Ketone Bodies as a Fuel. Circulation. 2016 Feb 23;133(8):698-705. doi: 10.1161/CIRCULATIONAHA.115.017355. Epub 2016 Jan 27.'}, {'pmid': '29915254', 'type': 'BACKGROUND', 'citation': 'Bertero E, Maack C. Metabolic remodelling in heart failure. Nat Rev Cardiol. 2018 Aug;15(8):457-470. doi: 10.1038/s41569-018-0044-6.'}, {'pmid': '30884964', 'type': 'BACKGROUND', 'citation': 'Nielsen R, Moller N, Gormsen LC, Tolbod LP, Hansson NH, Sorensen J, Harms HJ, Frokiaer J, Eiskjaer H, Jespersen NR, Mellemkjaer S, Lassen TR, Pryds K, Botker HE, Wiggers H. Cardiovascular Effects of Treatment With the Ketone Body 3-Hydroxybutyrate in Chronic Heart Failure Patients. Circulation. 2019 Apr 30;139(18):2129-2141. doi: 10.1161/CIRCULATIONAHA.118.036459.'}, {'pmid': '32351962', 'type': 'BACKGROUND', 'citation': 'Norwitz NG, Loh V. A Standard Lipid Panel Is Insufficient for the Care of a Patient on a High-Fat, Low-Carbohydrate Ketogenic Diet. Front Med (Lausanne). 2020 Apr 15;7:97. doi: 10.3389/fmed.2020.00097. eCollection 2020.'}, {'pmid': '31655093', 'type': 'BACKGROUND', 'citation': 'Soto-Mota A, Vansant H, Evans RD, Clarke K. Safety and tolerability of sustained exogenous ketosis using ketone monoester drinks for 28 days in healthy adults. Regul Toxicol Pharmacol. 2019 Dec;109:104506. doi: 10.1016/j.yrtph.2019.104506. Epub 2019 Oct 23.'}, {'pmid': '32096539', 'type': 'BACKGROUND', 'citation': 'Soto-Mota A, Norwitz NG, Clarke K. Why a d-beta-hydroxybutyrate monoester? Biochem Soc Trans. 2020 Feb 28;48(1):51-59. doi: 10.1042/BST20190240.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will evaluate the effect of a ketogenic diet and/or exogenous administration of ketone bodies vs conventional diet on the ejection fraction of patients with non-ischemic chronic heart failure, measuring MRI biomarkers.', 'detailedDescription': 'Evidence in both animals and humans suggests ketosis could be beneficial for people living with chronic heart failure. To date, no study has compared endogenous vs exogenous ketosis in patients with chronic heart failure. We will randomize (with a 1:1:1 ratio) patients with a confirmed diagnosis of non-ischemic chronic heart failure to undergo one of the following:\n\n1. \\- A ketogenic diet (\\<50 gr of carbohydrates per day) incorporating current recommendations for heart failure (low sodium and liquids) for 10 days.\n2. \\- Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days.\n3. \\- Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo.\n\nThe endpoints will be assessed using cardiac MRI and blood biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ejection fraction \\<40% minimum 1 month.\n* No change in optimum treatment 1 month at least.\n\nExclusion Criteria:\n\n* Ischemic cardiopathy (Angio-tomography corroborated cut-point \\>50% obstruction, coronary angiography, or cardiac scintigraphy 6 months at least) or angina pectoris symptoms.\n* Reynaud syndrome\n* Metformin or SGLT-2 Inhibitors treatment, Low BMI, nutritional deficiencies.\n* Creatinin clearance \\<30ml/min or renal replacement therapy\n* MRI contraindications (prothesis, Unsupported pacemakers, claustrophobia, etc)\n* Reynaud phenomenon history'}, 'identificationModule': {'nctId': 'NCT04921293', 'briefTitle': 'Comparison Between Endogenous and Exogenous Ketosis in Patients With Non-ischemic Chronic Heart Failure With Reduced Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Comparison Between Endogenous and Exogenous Ketosis in Patients With Non-ischemic Chronic Heart Failure With Reduced Ejection Fraction', 'orgStudyIdInfo': {'id': 'UIE-3652-21-22-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Diet', 'description': 'Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo.', 'interventionNames': ['Behavioral: Standard diet + placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Endogenous Ketosis', 'description': 'Ketogenic diet incorporating current recommendations for heart failure (\\<50gr of carbohydrates, low sodium, and liquids) for 10 days.', 'interventionNames': ['Behavioral: Ketogenic diet']}, {'type': 'EXPERIMENTAL', 'label': 'Exogenous ketosis', 'description': 'Standard incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days.', 'interventionNames': ['Dietary Supplement: Exogenous ketones']}], 'interventions': [{'name': 'Ketogenic diet', 'type': 'BEHAVIORAL', 'description': 'A diet with \\<50gr of carbohydrates per day. Monosaturated fats consumption will encourage over saturated fats', 'armGroupLabels': ['Endogenous Ketosis']}, {'name': 'Exogenous ketones', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Administration of ketone monoester 25 ml t.i.d', 'armGroupLabels': ['Exogenous ketosis']}, {'name': 'Standard diet + placebo', 'type': 'BEHAVIORAL', 'description': 'A standard diet incorporating current recommendations (low in sodium and low in liquids) for heart failure patients.', 'armGroupLabels': ['Standard Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Adrian Soto, Ph.D, MD.', 'role': 'CONTACT', 'email': 'adrian.sotom@incmnsz.com', 'phone': '5572191248'}], 'facility': 'INCMNSZ', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Adrian Soto, Ph.D, MD.', 'role': 'CONTACT', 'email': 'adrian.sotom@incmnsz.mx', 'phone': '5572191248'}, {'name': 'Jorge Oseguera, MD', 'role': 'CONTACT', 'email': 'jorge.osegueram@incmnsz.mx', 'phone': '54870900', 'phoneExt': '8210'}], 'overallOfficials': [{'name': 'Adrian Soto, Ph.D, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INCMNSZ'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'One year after publication', 'ipdSharing': 'YES', 'description': 'Upon request to PI', 'accessCriteria': 'Send email to adrian.sotom@incmnsz.mx'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}