Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900, Brazil
NCT Number: NCT03722069
This study is design to assess two levels of dietary sodium intake in the treatment of patients with Acute Decompensated Heart Failure.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Ribeirão Preto, São Paulo, 14048-900, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
Time frame: 7 days
The difference of the absolute value of serum sodium between the groups in the final evaluation.
Time frame: on day 7
The detection of serum level of sodium bellow 135 mmol/L
Time frame: 7 days
The difference of the absolute value of body weight between the initial and final values.
Time frame: 7 days
The difference of the absolute value of NT-proBNP between the initial and final values, and between groups.
Time frame: 7 days
The difference of the absolute value of blood pressure between the initial and final values.
Time frame: 7 days
The difference of the absolute value of heart rate between the initial and final values.
Time frame: 7 days
The difference of the absolute value of creatinine between the initial and final values.
Time frame: 7 days
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)
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)
Time frame: 7 days
What drugs will be used and the quantities.
Time frame: 30 days
Time frame: 30 days
University of Sao Paulo
Other
A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure
Acronym: SODIC
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.
Published trials that share one or more normalized conditions with this study.
NCT03387813
Cardiovascular Diseases, Heart Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT04145635
Cardio-Renal Syndrome, Cardiorenal Syndrome
Los Angeles, California, United States
View Trial DetailsNCT03200860
Cardiovascular Diseases, Heart Diseases
Emmen, Drenthe, Netherlands
View Trial DetailsNCT04281849
Cardiovascular Diseases, Heart Diseases
Aurora, Colorado, United States
View Trial Details