Dietary Sodium Intake in Acute Heart Failure

NCT03722069 | Completed

• 1 other identifier: 2383/2014
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure; With Decompensation; Heart Failure，Congestive

Keywords

Hyponatremia; Sodium Intake; Blood Pressure; Sodium Chloride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Occurrence of hyponatremia

  on day 7

• Change in body weight

  7 days

• Change in serum levels of NT-proBNP

  7 days

• Change in systolic, diastolic and mean blood pressure

  7 days

• Change in heart rate

  7 days

Study Arms (2)

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.

Other: Low sodium diet

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.

Other: Normal sodium diet

Interventions

Low sodium diet OTHER

Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.

Low sodium diet

Normal sodium diet OTHER

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

Normal sodium diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo: collaborator

Study Sites (1)

Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (4)

• 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.

  PMID: 23689381 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.

  PMID: 17688420 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.

  PMID: 19101237 BACKGROUND

• 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.

  PMID: 31221280 DERIVED

MeSH Terms

Conditions

Heart Failure; Hyponatremia

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Marcus V Simões, PhD

  Medical School of Ribeirao Preto, University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 26, 2018
• Study Start: July 20, 2014
• Primary Completion: August 20, 2017
• Study Completion: September 20, 2017
• Last Updated: October 31, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)