Dietary Sodium Intake in Acute Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure，Congestive; Heart Failure; With Decompensation

• Registration Number: NCT03722069
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-07-20
• Primary Completion: 2017-08-20
• Study Completion: 2017-09-20
• Status Verified: 2018-10
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-26
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Occurrence of hyponatremia	on day 7	The detection of serum level of sodium bellow 135 mmol/L
Diuretic dosage and other drugs to ADHF during intervention period	7 days	What drugs will be used and the quantities.
Change in serum levels of creatinine	7 days	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)	7 days
Rate of mortality after discharge	30 days
Change in body weight	7 days	The difference of the absolute value of body weight between the initial and final values.
Change in heart rate	7 days	The difference of the absolute value of heart rate between the initial and final values.
Change in dyspnea sense	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)
Change in well-being sense	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)
Change in serum levels of NT-proBNP	7 days	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	7 days	The difference of the absolute value of blood pressure between the initial and final values.
Rate of hospital readmission	30 days

Trial Locations

Locations (1)

Hospital das Clínicas de Ribeirão Preto; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil