Dietary Sodium Intake in Acute Heart Failure

Heart Failure,Congestive Clinical Trial

— SODIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722069
• Other study ID #: 2383/2014
• Status: Completed
• Phase: N/A
• Start date: July 20, 2014
• Est. completion date: September 20, 2017

Study information

• Verified date: October 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 20, 2017
• Est. primary completion date: August 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive
• Heart Failure; With Decompensation

Intervention

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
Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas de Ribeirão Preto	Ribeirao Preto	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of hyponatremia	The detection of serum level of sodium bellow 135 mmol/L	on day 7
Secondary	Change in body weight	The difference of the absolute value of body weight between the initial and final values.	7 days
Secondary	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
Secondary	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
Secondary	Change in heart rate	The difference of the absolute value of heart rate between the initial and final values.	7 days
Secondary	Change in serum levels of creatinine	The difference of the absolute value of creatinine between the initial and final values.	7 days
Secondary	Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL)		7 days
Secondary	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
Secondary	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
Secondary	Diuretic dosage and other drugs to ADHF during intervention period	What drugs will be used and the quantities.	7 days
Secondary	Rate of hospital readmission		30 days
Secondary	Rate of mortality after discharge		30 days