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| Name | Class |
|---|---|
| Coordenação de Aperfeiçoamento de Pessoal de NÃvel Superior. | OTHER_GOV |
| Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das ClÃnicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | OTHER |
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This study is design to assess two levels of dietary sodium intake in the treatment of patients with Acute Decompensated Heart Failure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low sodium diet | Other | 22 patients were randomized to receive 3 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day. |
|
| Normal sodium diet | Other | 22 patients were randomized to receive 7 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low sodium diet | Other | Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum sodium level at day 7 | The difference of the absolute value of serum sodium between the groups in the final evaluation. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of hyponatremia | The detection of serum level of sodium bellow 135 mmol/L | on day 7 |
| Change in body weight | The difference of the absolute value of body weight between the initial and final values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus V Simões, PhD | Medical School of Ribeirao Preto, University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas de Ribeirão Preto | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23689381 | Background | 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. | |
| 17688420 | Background | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D004039 | Diet, Sodium-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Normal sodium diet | Other | Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day. |
|
| 7 days |
| Change in serum levels of NT-proBNP | The difference of the absolute value of NT-proBNP between the initial and final values, and between groups. | 7 days |
| Change in systolic, diastolic and mean blood pressure | The difference of the absolute value of blood pressure between the initial and final values. | 7 days |
| Change in heart rate | The difference of the absolute value of heart rate between the initial and final values. | 7 days |
| Change in serum levels of creatinine | The difference of the absolute value of creatinine between the initial and final values. | 7 days |
| Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL) | 7 days |
| Change in dyspnea sense | 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) | 7 days |
| Change in well-being sense | 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) | 7 days |
| Diuretic dosage and other drugs to ADHF during intervention period | What drugs will be used and the quantities. | 7 days |
| Rate of hospital readmission | 30 days |
| Rate of mortality after discharge | 30 days |
| 19101237 | Background | 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. |
| 31221280 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |