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Dietary Sodium Intake in Acute Heart Failure (SODIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03722069
Recruitment Status : Completed
First Posted : October 26, 2018
Last Update Posted : October 31, 2018
Sponsor:
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
Information provided by (Responsible Party):
Camila Godoy Fabricio, University of Sao Paulo

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

Condition or disease Intervention/treatment Phase
Heart Failure; With Decompensation Heart Failure,Congestive Other: Low sodium diet Other: Normal sodium diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure
Actual Study Start Date : July 20, 2014
Actual Primary Completion Date : August 20, 2017
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Serum sodium level at day 7 [ Time Frame: 7 days ]
    The difference of the absolute value of serum sodium between the groups in the final evaluation.


Secondary Outcome Measures :
  1. Occurrence of hyponatremia [ Time Frame: on day 7 ]
    The detection of serum level of sodium bellow 135 mmol/L

  2. Change in body weight [ Time Frame: 7 days ]
    The difference of the absolute value of body weight between the initial and final values.

  3. Change in serum levels of NT-proBNP [ Time Frame: 7 days ]
    The difference of the absolute value of NT-proBNP between the initial and final values, and between groups.

  4. Change in systolic, diastolic and mean blood pressure [ Time Frame: 7 days ]
    The difference of the absolute value of blood pressure between the initial and final values.

  5. Change in heart rate [ Time Frame: 7 days ]
    The difference of the absolute value of heart rate between the initial and final values.

  6. Change in serum levels of creatinine [ Time Frame: 7 days ]
    The difference of the absolute value of creatinine between the initial and final values.

  7. Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL) [ Time Frame: 7 days ]
  8. Change in dyspnea sense [ Time Frame: 7 days ]
    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)

  9. Change in well-being sense [ Time Frame: 7 days ]
    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)

  10. Diuretic dosage and other drugs to ADHF during intervention period [ Time Frame: 7 days ]
    What drugs will be used and the quantities.

  11. Rate of hospital readmission [ Time Frame: 30 days ]
  12. Rate of mortality after discharge [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722069


Locations
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Brazil
Hospital das Clínicas de Ribeirão Preto
Ribeirao Preto, Sao Paulo, Brazil, 14048-900
Sponsors and Collaborators
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
Investigators
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Principal Investigator: Marcus V Simões, PhD Medical School of Ribeirao Preto, University of Sao Paulo
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Camila Godoy Fabricio, Master, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03722069    
Other Study ID Numbers: 2383/2014
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Camila Godoy Fabricio, University of Sao Paulo:
Hyponatremia
Sodium Intake
Blood Pressure
Sodium Chloride
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases