Dietary Sodium Intake in Acute Heart Failure (SODIC)

A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; With Decompensation; Heart Failure，Congestive
• Intervention / Treatment: Other: Low sodium diet; Other: Normal sodium diet

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Ribeirao Preto, Sao Paulo, Brazil, 14048-900
      • Hospital das Clinicas de Ribeirao Preto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

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

Publications and helpful links

General 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. 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2014
• Primary Completion (ACTUAL): August 20, 2017
• Study Completion (ACTUAL): September 20, 2017

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (ACTUAL): October 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Hyponatremia; Blood Pressure; Sodium Chloride; Sodium Intake
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2383/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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