Diet, Sodium-RestrictedSODA-HFNCT03351283
Effect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure
A study testing Severe sodium restriction and Moderate sodium restriction in people with Diet, Sodium-Restricted and Heart Failure, Systolic, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
The SODA-HF trial is a randomized, double-blind, controlled trial to evaluate the effect of moderate to severe sodium restriction on brain natriuretic peptide in patients with heart failure and reduced ejection fraction (less than 40%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diet, Sodium-Restricted, Heart Failure, Systolic, Natriuretic Peptide, Brain
- What is being tested?
- Severe sodium restriction and Moderate sodium restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMexico
- Study dates
- 22 Nov 2017to 1 Aug 2020
- 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 a diagnosis of stable heart failure and decreased left ventricular ejection fraction. Such definition will contemplate the following:
- Patients should have an echocardiogram of maximum 6 months old with a left ventricular ejection fraction of less than 40%.
- Functional class I, II or III of the NYHA
- Optimal medical treatment which should include: an angiotensin converting enzyme inhibitor or angiotensin receptor blocker ARA, and a beta-blocker; or inability to tolerate these medications.
- No changes in pharmacological treatment in the last 4 weeks.
- Systolic blood pressure greater than or equal to 90 mmHg.
- Informed consent to participate in the study.
Who cannot join
- A hospitalization for heart failure less than one month ago. Chronic kidney disease: glomerular filtration rate estimated by the formula of CKD-EPI <30 ml / min / 1.73 m2.
- Hyponatremia: Sodium less than 130 mmol / l. Anemia: Hemoglobin less than 10 g / dl. Patients who will be taken to any type of intervention in the next 12 months in order to improve ventricular function, such as percutaneous coronary intervention or surgical revascularization Any valvulopathy of severe degree. Dementia Cancer Patients who have planned change of address in the next 12 months.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital de Cardiología, Centro Médico Nacional Siglo XXI
Mexico City, 06720
About this study
Official title: Effect of Moderate vs Severe Sodium Restriction on Brain Natriuretic Peptide in Patients With Heart Failure and Reduced Ejection Fraction
The SODA-HF trial is a randomized, double-blind, controlled trial to evaluate the effect of moderate to severe sodium restriction on brain natriuretic peptide in patients with heart failure and reduced ejection fraction (less than 40%).
Secondary outcomes are quality of life, NYHA functional class, glomerular filtration rate, renin plasmatic activity, aldosterone and composite clinical outcome (all-cause mortality and cardiovascular hospitalization)
Read the detailed description
Allocation: Those patients who meet the selection criteria will go to the nutritionist who will make the assignment to one of the sodium restriction groups.
Generation of the sequence: patients will be assigned to the two groups based on a table of random numbers generated by a statistical analysis program. Blocks of 10 will be used.
Mechanism of concealment of the assignment: the nutritionist will be the only person who will know to which group the patient was assigned, the patient will not know to which group was assigned, neither will the researcher know. The person in charge of measuring the results will also be blinded.
Description of the intervention: the nutritionist will be the one to calculate diets appropriate to the needs of each of the patients. Patients will be allowed a maximum intake of 1.5 liters of water per day, including the liquid of soups, juices and drinks; This will be explained in detail to the patients. The diets will be identical in calories according to the weight of the patient. The only difference in diets will be the sodium content, which will be 3 grams of sodium vs. 2 grams of sodium.
Blinding: The patients, the researcher and those responsible for measuring the results will be blinded to the assignment of the intervention. Patients will not know which group they have been assigned to since they will not know the sodium content of the diet nor will they be aware of what diet the other patients were assigned to. Those responsible for conducting laboratory studies will not know to which group the patients have been assigned.
Blinding may be opened in the event that a patient suffers a severe adverse effect.
Follow-up: After assignment of the intervention, the patients will be cited at 6, 12 and 20 weeks. In Nutriology visits, the adherence of the intervention will be evaluated by means of a 24-hour diet reminder. According to the results obtained, the nutritionist will make recommendations in the diet to maintain a sodium intake of 3000 or 2000 mg according to the group to which hte patient has been assigned.
At the end of the intervention the natriuretic peptide value will be determined, as well as plasma activity of renin, aldosterone, GFR and the composite clinical outcome (all-cause mortality and cardiovascular hospitalization).
If a patient is hospitalized during the study, he will follow the treatment indicated by his treating doctor. Once the patient is discharged from the hospital, he will continue with previously scheduled follow-up appointments. If the sampling scheduled during the study coincides with an episode of unplanned hospitalization, the patient will wait until the patient has completed at least 4 weeks after discharge to take the corresponding samples.
If any patient dies during the study, he will be eliminated from the primary objective which is the determination of natriuretic peptide.
Monitoring of the study. Monitoring of information: Given that the study will be conducted in a single center, it is considered that a data monitoring committee will not be necessary.
Monitoring of patient safety: During the scheduled medical visits, a complete physical examination will be carried out with detailed attention to the signs and symptoms of heart failure. Weight, height, heart rate and systemic blood pressure will be measured. If a patient presents symptoms of heart failure exacerbation, he will be taken to the emergency department for a complete evaluation and adjustment of treatment.
According to the Mexican Official Norm 012-SSA3-2012, it will be considered adverse effect to the set of signs and symptoms not calculated and unexpected that appear in a research subject, and that potentially represent a risk to his health. If an adverse effect occurs, it will be notified no later than the business day following the corresponding Research Committee. In case of a severe adverse event (one that endangers the patient's life), the corresponding Research Committee will be notified immediately.
- Conditions
- Diet, Sodium-Restricted, Heart Failure, Systolic, Natriuretic Peptide, Brain, Clinical Trial
- Being tested
- Severe sodium restriction, Moderate sodium restriction
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe sodium restrictionOther
Patients will be assigned to a diet with sodium restriction of two grams.
Moderate sodium restrictionOther
Patients will be assigned to a diet with sodium restriction of three grams.
| Study group | Role | What they receive |
|---|---|---|
| Severe sodium restriction | Experimental | Patients will be assigned to a diet with two grams of sodium. The nutritionist will be responsible for calculating diets appropriate to the needs of each patient. The diet will not have the intention to modify the weight of the patient but only to indicate the menus that the patients will follow. All the patients will be explained the diet. Patients will be allowed a maximum intake of 1.5 liters of water per day, including the liquid of soups, juices and drinks; This will be explained in detail to the patients.
The diets will be identical in calories according to the weight of the patient. The only difference in diets will be the sodium content, which will be 2 grams of sodium vs. 3 grams of sodium. Receives: Other: Severe sodium restriction |
| Moderate sodium restriction. | Active comparator | Patients will be assigned to a diet with three grams of sodium. Receives: Other: Moderate sodium restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain natriuretic peptide
Brain natriuretic peptide (NT-proBNP) will be compared at the end of the intervention.
Measured: 20 weeks
Secondary outcomes (6)
Improvement in Quality of life
Quality of life will be compared with the Minnesota Living with Heart Failure Questionnaire. This is a self-applied questionnaire that contains 21 items, a total score and two dimensions: physical and emotional. The response options range from 0, which indicates unaffected quality of life, to 5, which indicates the maximum impact on the quality of life. The range of values of the questionnaire in general is 0-105; the physical dimension is 0-40; The emotional dimension is 0-25. In this study we will compare the overall result and the two dimensions.
Measured: 20 weeks
Measured glomerular filtration rate
Measured glomerular filtration rate will be assessed with 24-hour creatinine clearance.
Measured: 20 weeks
Renin plasmatic activity
Renin plasmatic activity will be assessed with ELISA.
Measured: 20 weeks
Aldosterone
Aldosterone will be assessed with ELISA.
Measured: 20 weeks
Composite clinical outcome
All-cause mortality or cardiovascular hospitalizations
Measured: 20 weeks
NYHA functional class
The range of the NYHA functional class is I to IV, where I is the patient with the best functional class and IV is a patient with the worst functional class.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start22 Nov 2017
- Primary completion1 Nov 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, Sodium-RestrictedStudies of the same condition, open and under way.
- 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
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eduardo Almeida Gutiérrez, Instituto Mexicano del Seguro Social
- Investigators
- Juan B Ivey-Miranda, MD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351283
- Sponsor's protocol ID
- Sodium and BNP
- Acronym
- SODA-HF
- Status last verified
- Sep 2020
- First submitted
- 20 Nov 2017
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be freely available but can be shared to certain investigators.
Publications
Ivey-Miranda JB, Almeida-Gutierrez E, Herrera-Saucedo R, Posada-Martinez EL, Chavez-Mendoza A, Mendoza-Zavala GH, Cigarroa-Lopez JA, Magana-Serrano JA, Rivera-Leanos R, Trevino-Mejia A, Revilla-Matute C, Flores-Umanzor EJ, Espinola-Zavaleta N, Orea-Tejeda A, Garduno-Espinosa J, Saturno-Chiu G, Rao VS, Testani JM, Borrayo-Sanchez G. Sodium restriction in patients with chronic heart failure and reduced ejection fraction: A randomized controlled trial. Cardiol J. 2023;30(3):411-421. doi: 10.5603/CJ.a2021.0098. Epub 2021 Sep 7.
PubMed 34490604
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moderate vs Severe Sodium Restriction on Brain Natriuretic Peptide in Patients With Heart Failure and Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT03351283
- Acronym / sponsor ID
- SODA-HF / Sodium and BNP
- Conditions
- Diet, Sodium-Restricted, Heart Failure, Systolic, Natriuretic Peptide, Brain, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 22 Nov 2017 (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.
The SODA-HF trial is a randomized, double-blind, controlled trial to evaluate the effect of moderate to severe sodium restriction on brain natriuretic peptide in patients with heart failure and reduced ejection fraction (less than 40%).
Secondary outcomes are quality of life, NYHA functional class, glomerular filtration rate, renin plasmatic activity, aldosterone and composite clinical outcome (all-cause mortality and cardiovascular hospitalization)
Detailed description
Allocation: Those patients who meet the selection criteria will go to the nutritionist who will make the assignment to one of the sodium restriction groups.
Generation of the sequence: patients will be assigned to the two groups based on a table of random numbers generated by a statistical analysis program. Blocks of 10 will be used.
Mechanism of concealment of the assignment: the nutritionist will be the only person who will know to which group the patient was assigned, the patient will not know to which group was assigned, neither will the researcher know. The person in charge of measuring the results will also be blinded.
Description of the intervention: the nutritionist will be the one to calculate diets appropriate to the needs of each of the patients. Patients will be allowed a maximum intake of 1.5 liters of water per day, including the liquid of soups, juices and drinks; This will be explained in detail to the patients. The diets will be identical in calories according to the weight of the patient. The only difference in diets will be the sodium content, which will be 3 grams of sodium vs. 2 grams of sodium.
Blinding: The patients, the researcher and those responsible for measuring the results will be blinded to the assignment of the intervention. Patients will not know which group they have been assigned to since they will not know the sodium content of the diet nor will they be aware of what diet the other patients were assigned to. Those responsible for conducting laboratory studies will not know to which group the patients have been assigned.
Blinding may be opened in the event that a patient suffers a severe adverse effect.
Follow-up: After assignment of the intervention, the patients will be cited at 6, 12 and 20 weeks. In Nutriology visits, the adherence of the intervention will be evaluated by means of a 24-hour diet reminder. According to the results obtained, the nutritionist will make recommendations in the diet to maintain a sodium intake of 3000 or 2000 mg according to the group to which hte patient has been assigned.
At the end of the intervention the natriuretic peptide value will be determined, as well as plasma activity of renin, aldosterone, GFR and the composite clinical outcome (all-cause mortality and cardiovascular hospitalization).
If a patient is hospitalized during the study, he will follow the treatment indicated by his treating doctor. Once the patient is discharged from the hospital, he will continue with previously scheduled follow-up appointments. If the sampling scheduled during the study coincides with an episode of unplanned hospitalization, the patient will wait until the patient has completed at least 4 weeks after discharge to take the corresponding samples.
If any patient dies during the study, he will be eliminated from the primary objective which is the determination of natriuretic peptide.
Monitoring of the study. Monitoring of information: Given that the study will be conducted in a single center, it is considered that a data monitoring committee will not be necessary.
Monitoring of patient safety: During the scheduled medical visits, a complete physical examination will be carried out with detailed attention to the signs and symptoms of heart failure. Weight, height, heart rate and systemic blood pressure will be measured. If a patient presents symptoms of heart failure exacerbation, he will be taken to the emergency department for a complete evaluation and adjustment of treatment.
According to the Mexican Official Norm 012-SSA3-2012, it will be considered adverse effect to the set of signs and symptoms not calculated and unexpected that appear in a research subject, and that potentially represent a risk to his health. If an adverse effect occurs, it will be notified no later than the business day following the corresponding Research Committee. In case of a severe adverse event (one that endangers the patient's life), the corresponding Research Committee will be notified immediately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe sodium restriction | Experimental | Other: Severe sodium restrictionPatients will be assigned to a diet with two grams of sodium. The nutritionist will be responsible for calculating diets appropriate to the needs of each patient. The diet will not have the intention to modify the weight of the patient but only to indicate the menus that the patients will follow. All the patients will be explained the diet. Patients will be allowed a maximum intake of 1.5 liters of water per day, including the liquid of soups, juices and drinks; This will be explained in detail to the patients. The diets will be identical in calories according to the weight of the patient. The only difference in diets will be the sodium content, which will be 2 grams of sodium vs. 3 grams of sodium. |
| Moderate sodium restriction. | Active comparator | Other: Moderate sodium restrictionPatients will be assigned to a diet with three grams of sodium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with a diagnosis of stable heart failure and decreased left ventricular ejection fraction. Such definition will contemplate the following:
- Patients should have an echocardiogram of maximum 6 months old with a left ventricular ejection fraction of less than 40%.
- Functional class I, II or III of the NYHA
- Optimal medical treatment which should include: an angiotensin converting enzyme inhibitor or angiotensin receptor blocker ARA, and a beta-blocker; or inability to tolerate these medications.
- No changes in pharmacological treatment in the last 4 weeks.
Key exclusion criteria (2 listed)
- A hospitalization for heart failure less than one month ago. Chronic kidney disease: glomerular filtration rate estimated by the formula of CKD-EPI <30 ml / min / 1.73 m2.
- Hyponatremia: Sodium less than 130 mmol / l. Anemia: Hemoglobin less than 10 g / dl. Patients who will be taken to any type of intervention in the next 12 months in order to improve ventricular function, such as percutaneous coronary intervention or surgical revascularization Any valvulopathy of severe degree. Dementia Cancer Patients who have planned change of address in the next 12 months.
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 |
|---|---|---|
| Severe sodium restrictionPatients will be assigned to a diet with sodium restriction of two grams. | Other | Severe sodium restriction |
| Moderate sodium restrictionPatients will be assigned to a diet with sodium restriction of three grams. | Other | Moderate sodium restriction. |
Primary outcome
Brain natriuretic peptide
Time frame: 20 weeks
Brain natriuretic peptide (NT-proBNP) will be compared at the end of the intervention.
6 secondary outcomes
Improvement in Quality of life
Time frame: 20 weeks
Measured glomerular filtration rate
Time frame: 20 weeks
Renin plasmatic activity
Time frame: 20 weeks
Aldosterone
Time frame: 20 weeks
Composite clinical outcome
Time frame: 20 weeks
NYHA functional class
Time frame: 20 weeks
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 9 Sep 2020.
- Derived from this study: PubMed 34490604Ivey-Miranda JB, Almeida-Gutierrez E, Herrera-Saucedo R, Posada-Martinez EL, Chavez-Mendoza A, Mendoza-Zavala GH, Cigarroa-Lopez JA, Magana-Serrano JA, Rivera-Leanos R, Trevino-Mejia A, Revilla-Matute C, Flores-Umanzor EJ, Espinola-Zavaleta N, Orea-Tejeda A, Garduno-Espinosa J, Saturno-Chiu G, Rao VS, Testani JM, Borrayo-Sanchez G. Sodium restriction in patients with chronic heart failure and reduced ejection fraction: A randomized controlled trial. Cardiol J. 2023;30(3):411-421. doi: 10.5603/CJ.a2021.0098. Epub 2021 Sep 7.
- Individual participant dataSharing planned: No. IPD will not be freely available but can be shared to certain investigators.
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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.
Juan B Ivey-Miranda, MD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Severe sodium restriction and Moderate sodium restriction in people with Diet, Sodium-Restricted and Heart Failure, Systolic, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 7 inclusion and 2 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 9 Sep 2020. 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 Mexico. 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?
Brain natriuretic peptide (time frame: 20 weeks). 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 NCT03351283, which also lists 1 linked publication.
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 9 Sep 2020.