Dietary Sodium Intake in Acute Heart Failure

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

Detailed Description
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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.

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

Conditions
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Heart Failure; With Decompensation, Heart Failure，Congestive

Intervention / Treatment
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* Other: Low sodium diet
* Other: Normal sodium diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low sodium diet<br>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<br>* Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.<br>|
| Other: Normal sodium diet<br>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<br>* Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum sodium level at day 7 | The difference of the absolute value of serum sodium between the groups in the final evaluation. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of hyponatremia | The detection of serum level of sodium bellow 135 mmol/L | on day 7 | 
| Change in body weight | The difference of the absolute value of body weight between the initial and final values. | 7 days | 
| 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. | 7 days | 
| Change in systolic, diastolic and mean blood pressure | The difference of the absolute value of blood pressure between the initial and final values. | 7 days | 
| Change in heart rate | The difference of the absolute value of heart rate between the initial and final values. | 7 days | 
| Change in serum levels of creatinine | The difference of the absolute value of creatinine between the initial and final values. | 7 days | 
| Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL) |  | 7 days | 
| 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) | 7 days | 
| 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) | 7 days | 
| Diuretic dosage and other drugs to ADHF during intervention period | What drugs will be used and the quantities. | 7 days | 
| Rate of hospital readmission |  | 30 days | 
| Rate of mortality after discharge |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyponatremia, Sodium Intake, Blood Pressure, Sodium Chloride