Heart Failure; With DecompensationSODICNCT03722069
Dietary Sodium Intake in Acute Heart Failure
A study testing Low sodium diet and Normal sodium diet in people with Heart Failure; With Decompensation and Heart Failure，Congestive, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study is design to assess two levels of dietary sodium intake in the treatment of patients with Acute Decompensated Heart Failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure; With Decompensation, Heart Failure，Congestive
- What is being tested?
- Low sodium diet and Normal sodium diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2014to 20 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Acute Decompensated Heart Failure diagnosis, filling the Framingham diagnostic criteria, hospitalized at campus Hospital das Clínicas of Ribeirão Preto.
Who cannot join
- Creatinine clearance <30 ml / min / 1.73 m²;
- Acute coronary syndrome;
- Stroke;
- Dementia;
- Severe cognitive impairment;
- Cancer;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure
This study is design to assess two levels of dietary sodium intake in the treatment of patients with Acute Decompensated Heart Failure.
Read the 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.
- Being tested
- Low sodium diet, Normal sodium diet
- Keywords
- Hyponatremia, Sodium Intake, Blood Pressure, Sodium Chloride
- Medical subject headings
- Heart Failure, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low sodium dietOther
Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
Normal sodium dietOther
Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
| Study group | Role | What they receive |
|---|---|---|
| Low sodium diet | Other | 22 patients were randomized to receive 3 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day. Receives: Other: Low sodium diet |
| Normal sodium diet | Other | 22 patients were randomized to receive 7 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day. Receives: Other: Normal sodium diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sodium level at day 7
The difference of the absolute value of serum sodium between the groups in the final evaluation.
Measured: 7 days
Secondary outcomes (12)
Occurrence of hyponatremia
The detection of serum level of sodium bellow 135 mmol/L
Measured: on day 7
Change in body weight
The difference of the absolute value of body weight between the initial and final values.
Measured: 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.
Measured: 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.
Measured: 7 days
Change in heart rate
The difference of the absolute value of heart rate between the initial and final values.
Measured: 7 days
Change in serum levels of creatinine
The difference of the absolute value of creatinine between the initial and final values.
Measured: 7 days
Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL)
Measured: 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)
Measured: 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)
Measured: 7 days
Diuretic dosage and other drugs to ADHF during intervention period
What drugs will be used and the quantities.
Measured: 7 days
Rate of hospital readmission
Measured: 30 days
Rate of mortality after discharge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start20 Jul 2014
- Primary completion20 Aug 2017
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure; With DecompensationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Camila Godoy Fabricio, University of Sao Paulo
- Investigators
- Marcus V Simões, PhD, Principal investigator, Medical School of Ribeirao Preto, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722069
- Sponsor's protocol ID
- 2383/2014
- Acronym
- SODIC
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23689381Paterna 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. doi: 10.1042/CS20070193.
PubMed 17688420Paterna 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.
PubMed 19101237Fabricio CG, Tanaka DM, Souza Gentil JR, Ferreira Amato CA, Marques F, Schwartzmann PV, Schmidt A, Simoes MV. A normal sodium diet preserves serum sodium levels during treatment of acute decompensated heart failure: A prospective, blind and randomized trial. Clin Nutr ESPEN. 2019 Aug;32:145-152. doi: 10.1016/j.clnesp.2019.03.009. Epub 2019 Apr 16.
PubMed 31221280
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT03722069
- Acronym / sponsor ID
- SODIC / 2383/2014
- Keywords
- Hyponatremia, Sodium Intake, Blood Pressure, Sodium Chloride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- 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
- Study start
- 20 Jul 2014 (actual)
- Primary completion
- 20 Aug 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low sodium diet | Other | Other: Low sodium diet22 patients were randomized to receive 3 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day. |
| Normal sodium diet | Other | Other: Normal sodium diet22 patients were randomized to receive 7 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Acute Decompensated Heart Failure diagnosis, filling the Framingham diagnostic criteria, hospitalized at campus Hospital das Clínicas of Ribeirão Preto.
Key exclusion criteria (12 listed)
- Creatinine clearance <30 ml / min / 1.73 m²;
- Acute coronary syndrome;
- Stroke;
- Dementia;
- Severe cognitive impairment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low sodium dietPatients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day. | Other | Low sodium diet |
| Normal sodium dietPatients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day. | Other | Normal sodium diet |
Primary outcome
Serum sodium level at day 7
Time frame: 7 days
The difference of the absolute value of serum sodium between the groups in the final evaluation.
12 secondary outcomes
Occurrence of hyponatremia
Time frame: on day 7
Change in body weight
Time frame: 7 days
Change in serum levels of NT-proBNP
Time frame: 7 days
Change in systolic, diastolic and mean blood pressure
Time frame: 7 days
Change in heart rate
Time frame: 7 days
Change in serum levels of creatinine
Time frame: 7 days
Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL)
Time frame: 7 days
Change in dyspnea sense
Time frame: 7 days
Change in well-being sense
Time frame: 7 days
Diuretic dosage and other drugs to ADHF during intervention period
Time frame: 7 days
Rate of hospital readmission
Time frame: 30 days
Rate of mortality after discharge
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Background: PubMed 23689381Aliti 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.
- Background: PubMed 17688420Paterna 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. doi: 10.1042/CS20070193.
- Background: PubMed 19101237Paterna 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.
- Derived from this study: PubMed 31221280Fabricio CG, Tanaka DM, Souza Gentil JR, Ferreira Amato CA, Marques F, Schwartzmann PV, Schmidt A, Simoes MV. A normal sodium diet preserves serum sodium levels during treatment of acute decompensated heart failure: A prospective, blind and randomized trial. Clin Nutr ESPEN. 2019 Aug;32:145-152. doi: 10.1016/j.clnesp.2019.03.009. Epub 2019 Apr 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus V Simões, PhD principal investigator
Medical School of Ribeirao Preto, University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low sodium diet and Normal sodium diet in people with Heart Failure; With Decompensation and Heart Failure，Congestive, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum sodium level at day 7 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722069, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.