Dietary Sodium Intake in Acute Heart Failure (SODIC)

• ClinicalTrials.gov Identifier: NCT03722069
• Recruitment Status: Completed
• First Posted: October 26, 2018
• Last Update Posted: October 31, 2018
• Sponsor: University of Sao Paulo
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
• Information provided by (Responsible Party): Camila Godoy Fabricio, University of Sao Paulo

Study Description

Brief Summary:

This study is design to assess two levels of dietary sodium intake in the treatment of patients with Acute Decompensated Heart Failure.

Condition or disease	Intervention/treatment	Phase
Heart Failure; With Decompensation; Heart Failure，Congestive	Other: Low sodium diet; Other: Normal sodium diet	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure
• Actual Study Start Date: July 20, 2014
• Actual Primary Completion Date: August 20, 2017
• Actual Study Completion Date: September 20, 2017

Arms and Interventions

Arm	Intervention/treatment
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.	Other: 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.	Other: Normal sodium diet; Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.

Outcome Measures

Primary Outcome Measures :

1. Serum sodium level at day 7 [ Time Frame: 7 days ]
   The difference of the absolute value of serum sodium between the groups in the final evaluation.

Secondary Outcome Measures :

1. Occurrence of hyponatremia [ Time Frame: on day 7 ]
   The detection of serum level of sodium bellow 135 mmol/L
2. Change in body weight [ Time Frame: 7 days ]
   The difference of the absolute value of body weight between the initial and final values.
3. Change in serum levels of NT-proBNP [ Time Frame: 7 days ]
   The difference of the absolute value of NT-proBNP between the initial and final values, and between groups.
4. Change in systolic, diastolic and mean blood pressure [ Time Frame: 7 days ]
   The difference of the absolute value of blood pressure between the initial and final values.
5. Change in heart rate [ Time Frame: 7 days ]
   The difference of the absolute value of heart rate between the initial and final values.
6. Change in serum levels of creatinine [ Time Frame: 7 days ]
   The difference of the absolute value of creatinine between the initial and final values.
7. Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL) [ Time Frame: 7 days ]
8. Change in dyspnea sense [ Time Frame: 7 days ]
   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)
9. Change in well-being sense [ Time Frame: 7 days ]
   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)
10. Diuretic dosage and other drugs to ADHF during intervention period [ Time Frame: 7 days ]
    What drugs will be used and the quantities.
11. Rate of hospital readmission [ Time Frame: 30 days ]
12. Rate of mortality after discharge [ Time Frame: 30 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients with Acute Decompensated Heart Failure diagnosis, filling the Framingham diagnostic criteria, hospitalized at campus Hospital das Clínicas of Ribeirão Preto.

Exclusion Criteria:

• Creatinine clearance <30 ml / min / 1.73 m²;
• 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.

Contacts and Locations

Locations

Brazil

Hospital das Clínicas de Ribeirão Preto

Ribeirao Preto, Sao Paulo, Brazil, 14048-900

Sponsors and Collaborators

University of Sao Paulo

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Investigators

• Principal Investigator: Marcus V Simões, PhD; Medical School of Ribeirao Preto, University of Sao Paulo

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fabricio CG, Tanaka DM, Souza Gentil JR, Ferreira Amato CA, Marques F, Schwartzmann PV, Schmidt A, Simões 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.

• Responsible Party: Camila Godoy Fabricio, Master, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT03722069
• Other Study ID Numbers: 2383/2014
• First Posted: October 26, 2018
• Last Update Posted: October 31, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Camila Godoy Fabricio, University of Sao Paulo:

Hyponatremia; Sodium Intake; Blood Pressure; Sodium Chloride

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases