Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-25 @ 2:40 AM
Study NCT ID:
NCT03722069
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2018-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Sodium Intake in Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007010', 'term': 'Hyponatremia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004039', 'term': 'Diet, Sodium-Restricted'}], 'ancestors': [{'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': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-29', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum sodium level at day 7', 'timeFrame': '7 days', 'description': 'The difference of the absolute value of serum sodium between the groups in the final evaluation.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of hyponatremia', 'timeFrame': 'on day 7', 'description': 'The detection of serum level of sodium bellow 135 mmol/L'}, {'measure': 'Change in body weight', 'timeFrame': '7 days', 'description': 'The difference of the absolute value of body weight between the initial and final values.'}, {'measure': 'Change in serum levels of NT-proBNP', 'timeFrame': '7 days', 'description': 'The difference of the absolute value of NT-proBNP between the initial and final values, and between groups.'}, {'measure': 'Change in systolic, diastolic and mean blood pressure', 'timeFrame': '7 days', 'description': 'The difference of the absolute value of blood pressure between the initial and final values.'}, {'measure': 'Change in heart rate', 'timeFrame': '7 days', 'description': 'The difference of the absolute value of heart rate between the initial and final values.'}, {'measure': 'Change in serum levels of creatinine', 'timeFrame': '7 days', 'description': 'The difference of the absolute value of creatinine between the initial and final values.'}, {'measure': 'Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL)', 'timeFrame': '7 days'}, {'measure': 'Change in dyspnea sense', 'timeFrame': '7 days', 'description': 'Using a visual anologic scale, with values between 0 and 10, where the minimum 0 is the greatest lack of air (worse) and the maximum 10 is the complete breath (better)'}, {'measure': 'Change in well-being sense', 'timeFrame': '7 days', 'description': 'Using a visual anologic scale, with values between 0 and 10, where the minimum 0 is the worse you ever felt (worse) and the maximum 10 is feel better than already (better)'}, {'measure': 'Diuretic dosage and other drugs to ADHF during intervention period', 'timeFrame': '7 days', 'description': 'What drugs will be used and the quantities.'}, {'measure': 'Rate of hospital readmission', 'timeFrame': '30 days'}, {'measure': 'Rate of mortality after discharge', 'timeFrame': '30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyponatremia', 'Sodium Intake', 'Blood Pressure', 'Sodium Chloride'], 'conditions': ['Heart Failure; With Decompensation', 'Heart Failure，Congestive']}, 'referencesModule': {'references': [{'pmid': '23689381', 'type': 'BACKGROUND', 'citation': 'Aliti GB, Rabelo ER, Clausell N, Rohde LE, Biolo A, Beck-da-Silva L. Aggressive fluid and sodium restriction in acute decompensated heart failure: a randomized clinical trial. JAMA Intern Med. 2013 Jun 24;173(12):1058-64. doi: 10.1001/jamainternmed.2013.552.'}, {'pmid': '17688420', 'type': 'BACKGROUND', 'citation': 'Paterna S, Gaspare P, Fasullo S, Sarullo FM, Di Pasquale P. Normal-sodium diet compared with low-sodium diet in compensated congestive heart failure: is sodium an old enemy or a new friend? Clin Sci (Lond). 2008 Feb;114(3):221-30. doi: 10.1042/CS20070193.'}, {'pmid': '19101237', 'type': 'BACKGROUND', 'citation': 'Paterna S, Parrinello G, Cannizzaro S, Fasullo S, Torres D, Sarullo FM, Di Pasquale P. Medium term effects of different dosage of diuretic, sodium, and fluid administration on neurohormonal and clinical outcome in patients with recently compensated heart failure. Am J Cardiol. 2009 Jan 1;103(1):93-102. doi: 10.1016/j.amjcard.2008.08.043. Epub 2008 Oct 17.'}, {'pmid': '31221280', 'type': 'DERIVED', 'citation': 'Fabricio CG, Tanaka DM, Souza Gentil JR, Ferreira Amato CA, Marques F, Schwartzmann PV, Schmidt A, Simoes MV. A normal sodium diet preserves serum sodium levels during treatment of acute decompensated heart failure: A prospective, blind and randomized trial. Clin Nutr ESPEN. 2019 Aug;32:145-152. doi: 10.1016/j.clnesp.2019.03.009. Epub 2019 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'This study is design to assess two levels of dietary sodium intake in the treatment of patients with Acute Decompensated Heart Failure.', 'detailedDescription': 'This study aim at assessing the effect of two levels of dietary sodium intake during seven days in hospitalized patients with Acute Decompensated Heart Failure. It is a prospective cohort, randomized, with blinded intervention groups: low sodium diet (the patients will receive 3 g/day of dietary sodium intake), and normal sodium diet (patients will receive 7 g/day of dietary sodium intake). Besides that, both groups will be submitted to a fluid intake limited to 1000 ml/day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Acute Decompensated Heart Failure diagnosis, filling the Framingham diagnostic criteria, hospitalized at campus Hospital das Clínicas of Ribeirão Preto.\n\nExclusion Criteria:\n\n* Creatinine clearance \\<30 ml / min / 1.73 m²;\n* Acute coronary syndrome;\n* Stroke;\n* Dementia;\n* Severe cognitive impairment;\n* Cancer;\n* Decompensated diabetes mellitus;\n* Severe liver disease;\n* Septic shock or with clinical signs of sepsis;\n* Chronic renal parenchymal disease prior to the start of the study;\n* ADHF secondary to acute renal failure;\n* Nutritional disorders or those who are unable to take oral intake because of vomiting, dysphagia or gastroenteritis.'}, 'identificationModule': {'nctId': 'NCT03722069', 'acronym': 'SODIC', 'briefTitle': 'Dietary Sodium Intake in Acute Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': '2383/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low sodium diet', 'description': '22 patients were randomized to receive 3 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.', 'interventionNames': ['Other: Low sodium diet']}, {'type': 'OTHER', 'label': 'Normal sodium diet', 'description': '22 patients were randomized to receive 7 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.', 'interventionNames': ['Other: Normal sodium diet']}], 'interventions': [{'name': 'Low sodium diet', 'type': 'OTHER', 'description': 'Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.', 'armGroupLabels': ['Low sodium diet']}, {'name': 'Normal sodium diet', 'type': 'OTHER', 'description': 'Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.', 'armGroupLabels': ['Normal sodium diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas de Ribeirão Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Marcus V Simões, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical School of Ribeirao Preto, University of Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}, {'name': 'Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master', 'investigatorFullName': 'Camila Godoy Fabricio', 'investigatorAffiliation': 'University of Sao Paulo'}}}}