Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-30 @ 7:10 PM
Study NCT ID:
NCT01115504
Status:
COMPLETED
Last Update Posted:
2010-12-23
First Post:
2010-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy
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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-22', 'studyFirstSubmitDate': '2010-05-03', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea score', 'timeFrame': '30 days', 'description': 'scores are given by the patients from 1 to 7 to dyspnea and are reevaluted after 30 days of intervention'}], 'secondaryOutcomes': [{'measure': 'Edema score', 'timeFrame': '30 days', 'description': 'Edema is scored 1 to 7 by a physician and reevaluated 30days later after intervention'}, {'measure': 'Systolic function', 'timeFrame': '30 days', 'description': 'ejection fraction, lateral and septal Sm wave (measured by tissue doppler) are evaluetad by echocardiography before and after intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thiamine', 'heart failure'], 'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'The study is performed to consider the effect of thiamine supplementation on symptoms and signs of patients with heart failure and systolic and diastolic function of left ventricle.', 'detailedDescription': 'The study is performed to consider the effect of thiamine supplementation versus placebo on symptoms and signs of patients with heart failure systolic and diastolic function of left ventricle.\n\nHeart failure patients (left ventricular ejection fraction (LVEF ≤ 40%) are randomized to receive tablets of 300mg or placebo for 1 months in a double-blind fashion. All subjects will be on stable optimal medical therapy according to the present guidelines for at least 3 months before enrolment. At randomization and at study end, echocardiography by a single observer will be performed and assessment of symptoms and signs and quality of life based on self scoring system (from 1 to 7) and objective physical examinations will be done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%)\n* Optimal medical therapy according to the present guidelines for at least 3 months before enrollment.\n\nExclusion Criteria:\n\n* Decompensated heart failure\n* Renal failure\n* COPD\n* Asthma\n* Uncontrolled hypertension\n* Bradycardia or tachycardia which needs increase or decrease in medications'}, 'identificationModule': {'nctId': 'NCT01115504', 'briefTitle': 'Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'officialTitle': 'Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy', 'orgStudyIdInfo': {'id': 'THF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thiamine', 'description': 'Thiamine tablets of 300mg are prescribed for 1 months', 'interventionNames': ['Drug: Thiamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Plascebo', 'description': 'Tablets of 300mg placebo are prescribed for 1 months', 'interventionNames': ['Drug: Thiamine']}], 'interventions': [{'name': 'Thiamine', 'type': 'DRUG', 'otherNames': ['Thiamine: brand name: Thiamine Hakim'], 'description': '300 mg daily for 30 days', 'armGroupLabels': ['Plascebo', 'Thiamine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shahrood', 'state': 'Semnan Province', 'country': 'Iran', 'facility': 'Faculty of medicine, Azad university'}], 'overallOfficials': [{'name': 'Mehdi Mousavi, Cardiologist', 'role': 'STUDY_CHAIR', 'affiliation': 'Azad university'}, {'name': 'Said Namazi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Azad university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mehdi Mousavi', 'oldOrganization': 'Azad university'}}}}