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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03722069
Other study ID # 2383/2014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2014
Est. completion date September 20, 2017

Study information

Verified date October 2018
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 information / eligibility

Status Completed
Enrollment 44
Est. completion date September 20, 2017
Est. primary completion date August 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Low sodium diet
Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
Normal sodium diet
Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.

Locations

Country Name City State
Brazil Hospital das Clínicas de Ribeirão Preto Ribeirao Preto Sao Paulo

Sponsors (3)

Lead Sponsor Collaborator
University of Sao Paulo Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Aliti GB, Rabelo ER, Clausell N, Rohde LE, Biolo A, Beck-da-Silva L. Aggressive fluid and sodium restriction in acute decompensated heart failure: a randomized clinical trial. JAMA Intern Med. 2013 Jun 24;173(12):1058-64. doi: 10.1001/jamainternmed.2013.552. — View Citation

Paterna S, Gaspare P, Fasullo S, Sarullo FM, Di Pasquale P. Normal-sodium diet compared with low-sodium diet in compensated congestive heart failure: is sodium an old enemy or a new friend? Clin Sci (Lond). 2008 Feb;114(3):221-30. — View Citation

Paterna S, Parrinello G, Cannizzaro S, Fasullo S, Torres D, Sarullo FM, Di Pasquale P. Medium term effects of different dosage of diuretic, sodium, and fluid administration on neurohormonal and clinical outcome in patients with recently compensated heart failure. Am J Cardiol. 2009 Jan 1;103(1):93-102. doi: 10.1016/j.amjcard.2008.08.043. Epub 2008 Oct 17. — View Citation

Outcome

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