Dietary Sodium Intake in Acute Heart Failure
- Conditions
- Heart Failure，CongestiveHeart Failure; With Decompensation
- Interventions
- Other: Normal sodium dietOther: Low sodium diet
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Patients with Acute Decompensated Heart Failure diagnosis, filling the Framingham diagnostic criteria, hospitalized at campus Hospital das Clínicas of Ribeirão Preto.
- 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
- Arm && Interventions
Group Intervention Description Normal sodium diet 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. Low sodium diet 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.
- 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