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Dietary Sodium Intake in Acute Heart Failure (SODIC)

U

University of Sao Paulo

Status

Completed

Conditions

Heart Failure; With Decompensation
Heart Failure,Congestive

Treatments

Other: Low sodium diet
Other: Normal sodium diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03722069
2383/2014

Details and patient eligibility

About

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

Full 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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

44 participants in 2 patient groups

Low sodium diet
Other group
Description:
22 patients were randomized to receive 3 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.
Treatment:
Other: Low sodium diet
Normal sodium diet
Other group
Description:
22 patients were randomized to receive 7 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.
Treatment:
Other: Normal sodium diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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