Clinical trial NCT03722069: Dietary Sodium Intake in Acute Heart Failure
Official title: A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure; With Decompensation
Heart Failure，Congestive
Keywords: Hyponatremia
Sodium Intake
Blood Pressure
Sodium Chloride
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
First posted: 2018-10-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Serum sodium level at day 7
timeFrame: 7 days
Secondary outcomes:
measure: Occurrence of hyponatremia
timeFrame: on day 7
measure: Change in body weight
timeFrame: 7 days
measure: Change in serum levels of NT-proBNP
timeFrame: 7 days
measure: Change in systolic, diastolic and mean blood pressure
timeFrame: 7 days
measure: Change in heart rate
timeFrame: 7 days
measure: Change in serum levels of creatinine
timeFrame: 7 days
measure: Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL)
timeFrame: 7 days
measure: Change in dyspnea sense
timeFrame: 7 days
measure: Change in well-being sense
timeFrame: 7 days
measure: Diuretic dosage and other drugs to ADHF during intervention period
timeFrame: 7 days
measure: Rate of hospital readmission
timeFrame: 30 days
measure: Rate of mortality after discharge
timeFrame: 30 days
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clínicas de Ribeirão Preto
state: Sao Paulo
Study officials:
affiliation: Medical School of Ribeirao Preto, University of Sao Paulo
name: Marcus V Simões, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1042/CS20070193.
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.
citation: 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.