search
Back to results

Dietary Sodium Intake in Acute Heart Failure (SODIC)

Primary Purpose

Heart Failure; With Decompensation, Heart Failure，Congestive

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low sodium diet
Normal sodium diet
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure; With Decompensation focused on measuring Hyponatremia, Sodium Intake, Blood Pressure, Sodium Chloride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital das Clínicas de Ribeirão Preto

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Low sodium diet

Normal sodium diet

Arm Description

22 patients were randomized to receive 3 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.

22 patients were randomized to receive 7 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.

Outcomes

Primary Outcome Measures

Serum sodium level at day 7
The difference of the absolute value of serum sodium between the groups in the final evaluation.

Secondary Outcome Measures

Occurrence of hyponatremia
The detection of serum level of sodium bellow 135 mmol/L
Change in body weight
The difference of the absolute value of body weight between the initial and final values.
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.
Change in systolic, diastolic and mean blood pressure
The difference of the absolute value of blood pressure between the initial and final values.
Change in heart rate
The difference of the absolute value of heart rate between the initial and final values.
Change in serum levels of creatinine
The difference of the absolute value of creatinine between the initial and final values.
Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL)
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)
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)
Diuretic dosage and other drugs to ADHF during intervention period
What drugs will be used and the quantities.
Rate of hospital readmission
Rate of mortality after discharge

Full Information

First Posted
October 24, 2018
Last Updated
October 29, 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
search

1. Study Identification

Unique Protocol Identification Number
NCT03722069
Brief Title
Dietary Sodium Intake in Acute Heart Failure
Acronym
SODIC
Official Title
A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 20, 2014 (Actual)
Primary Completion Date
August 20, 2017 (Actual)
Study Completion Date
September 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure; With Decompensation, Heart Failure，Congestive
Keywords
Hyponatremia, Sodium Intake, Blood Pressure, Sodium Chloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low sodium diet
Arm Type
Other
Arm Description
22 patients were randomized to receive 3 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.
Arm Title
Normal sodium diet
Arm Type
Other
Arm Description
22 patients were randomized to receive 7 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.
Intervention Type
Other
Intervention Name(s)
Low sodium diet
Intervention Description
Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
Intervention Type
Other
Intervention Name(s)
Normal sodium diet
Intervention Description
Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
Primary Outcome Measure Information:
Title
Serum sodium level at day 7
Description
The difference of the absolute value of serum sodium between the groups in the final evaluation.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Occurrence of hyponatremia
Description
The detection of serum level of sodium bellow 135 mmol/L
Time Frame
on day 7
Title
Change in body weight
Description
The difference of the absolute value of body weight between the initial and final values.
Time Frame
7 days
Title
Change in serum levels of NT-proBNP
Description
The difference of the absolute value of NT-proBNP between the initial and final values, and between groups.
Time Frame
7 days
Title
Change in systolic, diastolic and mean blood pressure
Description
The difference of the absolute value of blood pressure between the initial and final values.
Time Frame
7 days
Title
Change in heart rate
Description
The difference of the absolute value of heart rate between the initial and final values.
Time Frame
7 days
Title
Change in serum levels of creatinine
Description
The difference of the absolute value of creatinine between the initial and final values.
Time Frame
7 days
Title
Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL)
Time Frame
7 days
Title
Change in dyspnea sense
Description
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)
Time Frame
7 days
Title
Change in well-being sense
Description
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)
Time Frame
7 days
Title
Diuretic dosage and other drugs to ADHF during intervention period
Description
What drugs will be used and the quantities.
Time Frame
7 days
Title
Rate of hospital readmission
Time Frame
30 days
Title
Rate of mortality after discharge
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus V Simões, PhD
Organizational Affiliation
Medical School of Ribeirao Preto, University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas de Ribeirão Preto
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14048-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23689381
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.
Results Reference
background
PubMed Identifier
17688420
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.
Results Reference
background
PubMed Identifier
19101237
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.
Results Reference
background
PubMed Identifier
31221280
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.
Results Reference
derived

Learn more about this trial

Dietary Sodium Intake in Acute Heart Failure

We'll reach out to this number within 24 hrs