Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04698005
Status:
UNKNOWN
Last Update Posted:
2021-01-06
First Post:
2020-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exogenous Ketones for Acutely Decompensated HEart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002303', 'term': 'Cardiac Output, Low'}, {'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The participant and the physician in charge of the participant will be blinded to the given treatment (ketone drink vs. placebo)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomisation 1:1 to active treatment (exogenous ketones) vs. placebo (drinking water of equivalent volume)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum change of stroke volume index', 'timeFrame': 'Maximum value of stroke volume index measured between hour 1 - 3 of the study protocol at 15-minute intervals', 'description': 'Maximum change of stroke volume index (ml/m2) between baseline and hour 1 - 3'}, {'measure': 'Maximum change of cardiac index', 'timeFrame': 'Maximum value of cardiac index measured between hour 1 - 3 of the study protocol at 15-minute intervals', 'description': 'Maximum change of cardiac index (L/m2) between baseline and hour 1 - 3'}, {'measure': 'Change of mean stroke volume index', 'timeFrame': 'Mean value of stroke volume index measured every 15 minutes during 9 hours of the study protocol', 'description': 'Difference between baseline stroke volume index and mean stroke volume index (ml/m2) during the study protocol'}, {'measure': 'Change of mean cardiac index', 'timeFrame': 'Mean value of cardiac index measured every 15 minutes during 9 hours of the study protocol', 'description': 'Difference between baseline cardiac index (L/m2) and mean cardiac index during the study protocol'}], 'secondaryOutcomes': [{'measure': 'Change in patient/symptoms', 'timeFrame': 'Symptoms scored at hours 0, 1, 10, 24 and expressed as an area under the curve', 'description': 'Change in patient-referred symptoms by visual-analog scale (1=unbearable dyspnea, 10=no symptoms)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Heart Failure', 'Low Cardiac Output Syndrome', 'Hemodynamic Instability', 'Ketosis']}, 'descriptionModule': {'briefSummary': "This study will evaluate whether supplementation of exogenous ketones in patients with severe left ventricular dysfunction and acutely decompensated heart failure requiring inotropic therapy would improve the patient's hemodynamics and symptoms.", 'detailedDescription': 'The study will include patients with acutely decompensated chronic heart failure requiring inotropic therapy for the syndrome of low cardiac output. While being on the inotropic therapy, the patients will be randomized to oral supplementation of exogenous ketones vs. placebo, which will be repeatedly administered over 9 hours. The patients will undergo continuous invasive hemodynamic monitoring by pulmonary artery catheter, repeated laboratory assessment, and repeated assessment of the severity of symptoms for 24 hours.\n\nExogenous ketones will be administered orally using monoester 3-OHB concentrate without added salts (25g 3-OHB in 65ml H.V.M.N Ketone Ester, H.V.M.N, USA or equivalent). The drink will be administered over 10 mins every 3 hours, 3 times in a row (hour 0, 3, 6).\n\nAll patients with K\\<3.7 mmol/l will receive a continuous infusion of 7.5% potassium until reach target K levels of 4.0-4.9 mmol /l. Glycemia will be controlled as needed by insulin and dextrose to maintain glucose concentration of 4 - 12 mmol/l\n\nAll patients will receive standard treatment of acute heart failure, including intravenous diuretics and inotropic therapy. The recommended inotropic therapy will include milrinone 0.5 ug/kg/min, levosimendan 0.1 ug/kg/min up to 25mg without initial bolus, or dobutamine 0.5 ug/kg/min in patients without chronic therapy with beta-blockers.\n\nThe severity of symptoms will be self-reported by the patient using 1-10 visual analog scale.\n\nWorkflow:\n\n* Hemodynamic assessment, assessment of ketones concentration: 1-3h before randomization, 0-9h hourly, 16-24h (next morning)\n* Biochemical assessment (renal function, liver enzymes, BNP, hs-TnT) 0h, 9h, 16-24h\n* Assessment of symptoms and Scv02: 0h, 1h, 3h, 9h, 16-24h\n\nStatistical methods:\n\nEach study arm will include 12 patients. The study size was estimated to have power of (1 - beta) of 0.8 and alpha of 5% for between-group comparison of changes in cardiac index and stroke volume index by ANOVA and for comparison of the changes in cardiac index and stroke volume index by paired t-tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic heart failure due ischemic or nonischemic cardiomyopathy\n* Acute decompensation of heart failure with the need of inotropes\n* Achievement of relative stabilization on inotropes (INTERMACS class \\>2)\n* Left ventricular ejection fraction \\<= 35%\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Deteriorating cardiogenic shock with likely need of mechanical circulatory support in the subsequent 48 hours\n* Chronic kidney disease grade 4 or 5\n* Diabetic ketoacidosis (3-OHB \\>2mmol/l at baseline)\n* Hemodynamic severe arrhythmias\n* Acute heart failure due to transient triggers (acute coronary syndrome, atrial fibrillation, infection etc..)\n* Contraindications to invasive hemodynamic monitoring'}, 'identificationModule': {'nctId': 'NCT04698005', 'acronym': 'KADHEF', 'briefTitle': 'Exogenous Ketones for Acutely Decompensated HEart Failure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute for Clinical and Experimental Medicine'}, 'officialTitle': 'Exogenous Ketones for Acutely Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'A-20-28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplementation of exogenous ketones', 'description': 'Exogeneous ketones will be administered orally using monoester 3-OHB concentrate without added salts (25g 3-OHB in 65ml H.V.M.N Ketone Ester, H.V.M.N, USA or equivalent). The drink will be administered over 10 mins every 3 hours, 3 times in a row.', 'interventionNames': ['Dietary Supplement: 25g Ketone monoester without added salts']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The patients will receive a placebo drink (drinking water) of equivalent volume (3x 65ml)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '25g Ketone monoester without added salts', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['25g 3-OHB in 65ml, H.V.M.N Ketone Ester, H.V.M.N, USA or equivalent'], 'description': 'oral supplementation of ketone monoester', 'armGroupLabels': ['Supplementation of exogenous ketones']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The patients will receive a placebo drink (drinking water) of equivalent volume (3x 65ml)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14059', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Marek Sramko, MD, PhD', 'role': 'CONTACT', 'email': 'marek.sramko@ikem.cz', 'phone': '+420731682681'}], 'facility': 'Institute for Clinical and Experimental Medicine (IKEM)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Marek Sramko, MD, PhD', 'role': 'CONTACT', 'email': 'marek.sramko@ikem.cz', 'phone': '+420776246127'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Acute Cardiology', 'investigatorFullName': 'Marek Sramko', 'investigatorAffiliation': 'Institute for Clinical and Experimental Medicine'}}}}