Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-11 @ 11:55 PM
Study NCT ID:
NCT00680706
Status:
COMPLETED
Last Update Posted:
2013-08-21
First Post:
2008-05-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thiamine and Acute Decompensated Heart Failure: Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013831', 'term': 'Thiamine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'howard.smithline@baystatehealth.org', 'phone': '413-794-3433', 'title': 'Howard Smithline', 'organization': 'Baystate Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Thiamine', 'description': 'Receives thiamine', 'otherNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Receives placebo', 'otherNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Thiamine Supplementation on Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'Thiamine'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '40'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '37'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Effect of Thiamine Supplementation on Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'Thiamine'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '26'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '34'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8-Hour', 'description': 'Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thiamine', 'description': 'Receives thiamine, 100 mg intravenously at baseline (time 0-hour) and again at time 24-hour.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Receives placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Recruitment: January 2008 to February 2010 Location: Emergency Department', 'preAssignmentDetails': 'One subject was dropped by the PI after consent but before randomization because the subject did not meet the inclusion/exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Thiamine', 'description': 'Receives thiamine'}, {'id': 'BG001', 'title': 'Control', 'description': 'Receives placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '13', 'groupId': 'BG000'}, {'value': '73', 'spread': '13', 'groupId': 'BG001'}, {'value': '73', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-12', 'studyFirstSubmitDate': '2008-05-16', 'resultsFirstSubmitDate': '2012-07-27', 'studyFirstSubmitQcDate': '2008-05-16', 'lastUpdatePostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-29', 'studyFirstPostDateStruct': {'date': '2008-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Thiamine Supplementation on Dyspnea', 'timeFrame': 'Baseline', 'description': 'Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.'}, {'measure': 'Effect of Thiamine Supplementation on Dyspnea', 'timeFrame': '8-Hour', 'description': 'Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '31060559', 'type': 'DERIVED', 'citation': 'Smithline HA, Donnino M, Blank FSJ, Barus R, Coute RA, Knee AB, Visintainer P. Supplemental thiamine for the treatment of acute heart failure syndrome: a randomized controlled trial. BMC Complement Altern Med. 2019 May 6;19(1):96. doi: 10.1186/s12906-019-2506-8.'}]}, 'descriptionModule': {'briefSummary': 'Heart failure remains an increasing cause of morbidity and mortality in the United States even in the face of recent advances in the treatment of cardiovascular disease. There is an urgent need to reevaluate the treatment of heart failure. Shifting substrate utilization used in energy metabolism from fatty acids to glucose is beneficial to the heart presumably by increasing the efficiency of ATP production. Several new drugs for the treatment of cardiac ischemia work by this mechanism. There is increasing evidence that patients with heart failure may also benefit by the same type of intervention. Patients with heart failure are known to have low serum thiamine levels because of poor dietary intake and increased urinary excretion. Inadequate thiamine will deleteriously shift substrate utilization from glucose to fatty acids.\n\nWe hypothesize that thiamine supplementation will be beneficial for patients with heart failure by increasing glucose and decreasing fatty acid utilization. This will be initially tested in a pilot double-blinded placebo controlled study of thiamine supplementation in diabetic and non-diabetic patients presenting to the emergency department with acute decompensated heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. History of heart failure on a loop diuretic.\n2. Worsening dyspnea over the past 24 hours.\n3. Currently dyspneic sitting or supine, on or off oxygen.\n4. Radiographic cephalization of vessels. This criteria is not needed if the patient has no other reason for being dyspneic after being evaluated in the emergency department.\n5. Elevated NT pro-BNP (\\>450).\n6. Able to communicate in English or Spanish.\n7. Able and willing to provide informed consent.\n8. Age \\> 18 years.\n9. A primary admitting diagnosis of acute decompensated heart failure.\n\nExclusion Criteria:\n\n1. Renal failure on dialysis.\n2. Severe valvular disease.\n3. EKG criteria for acute myocardial infarction (ST segment elevation \\> 1mm on two contiguous leads).\n4. Initial troponin elevated.\n5. Ventricular arrhythmia (ventricular tachycardia or fibrillation).\n6. Supraventricular arrhythmia (atrial fibrillation / flutter) with a ventricular rate \\>120 beats per minute.\n7. Taking a daily thiamine supplementation (any multivitamin or specific thiamine supplementation within the past 2 weeks. Fortified foods, such as cereals, are acceptable\n8. Taking a daily fatty acid supplement.\n9. Pregnancy as determined by standard serum or urine b-HCG assay.'}, 'identificationModule': {'nctId': 'NCT00680706', 'briefTitle': 'Thiamine and Acute Decompensated Heart Failure: Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Baystate Medical Center'}, 'officialTitle': 'Targeting Myocardial Energy Metabolism for the Treatment of Acute Heart Failure: The Effect of Thiamine on Biochemical, Electrocardiographic and Respiratory Parameters in Hospitalized Patients.', 'orgStudyIdInfo': {'id': '07-059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thiamine', 'description': 'Receives thiamine', 'interventionNames': ['Drug: Thiamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Thiamine', 'type': 'DRUG', 'otherNames': ['Vitamin B1'], 'description': 'Thiamine (100 mg) in 50 ml D5W, x 2.', 'armGroupLabels': ['Thiamine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'D5W (50 ml)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}], 'overallOfficials': [{'name': 'Howard Smithline, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baystate Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baystate Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Emergency Medicine Research', 'investigatorFullName': 'Howard Smithline', 'investigatorAffiliation': 'Baystate Medical Center'}}}}