Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2014-07-20
2017-09-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low sodium diet
22 patients were randomized to receive 3 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.
Low sodium diet
Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
Normal sodium diet
22 patients were randomized to receive 7 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.
Normal sodium diet
Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
Interventions
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Low sodium diet
Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
Normal sodium diet
Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Acute coronary syndrome;
* Stroke;
* Dementia;
* Severe cognitive impairment;
* Cancer;
* Decompensated diabetes mellitus;
* Severe liver disease;
* Septic shock or with clinical signs of sepsis;
* Chronic renal parenchymal disease prior to the start of the study;
* ADHF secondary to acute renal failure;
* Nutritional disorders or those who are unable to take oral intake because of vomiting, dysphagia or gastroenteritis.
18 Years
ALL
No
Sponsors
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
OTHER
University of Sao Paulo
OTHER
Responsible Party
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Camila Godoy Fabricio
Master
Principal Investigators
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Marcus V Simões, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical School of Ribeirao Preto, University of Sao Paulo
Locations
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Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2383/2014
Identifier Type: -
Identifier Source: org_study_id