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Completed

NCT Number: NCT03722069

Dietary Sodium Intake in Acute Heart Failure

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low sodium diet

Other

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

Normal sodium diet

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

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

Registry information

Official study title

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

Acronym: SODIC

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2018
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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