An interventional study of Severe sodium restriction and Moderate sodium restriction in Diet, Sodium-Restricted, Heart Failure, Systolic and Natriuretic Peptide, Brain, sponsored by Instituto Mexicano del Seguro Social. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by Instituto Mexicano del Seguro Social · Not applicable, Interventional, and Treatment
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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)
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.
230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 165 interventional studies indexed under Heart Failure, Systolic.
Browse Heart Failure, Systolic studies →Instituto Mexicano del Seguro Social is the lead sponsor of 126 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with a diagnosis of stable heart failure and decreased . Such definition will contemplate the following:
Exclusion Criteria:
A hospitalization for heart failure less than one month ago. Chronic kidney disease: estimated by the formula of CKD-EPI \<30 ml / min / 1.73 m2.
Hyponatremia: Sodium less than 130 mmol / l. Anemia: 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Severe sodium restriction
Patients will be assigned to a diet with three grams of sodium.
Other: Moderate sodium restriction
Patients will be assigned to a diet with sodium restriction of two grams.
Patients will be assigned to a diet with sodium restriction of three grams.
Brain natriuretic peptide
Brain natriuretic peptide (NT-proBNP) will be compared at the end of the intervention.
Time frame: 20 weeks
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.
Time frame: 20 weeks
Measured glomerular filtration rate
Measured glomerular filtration rate will be assessed with 24-hour creatinine clearance.
Time frame: 20 weeks
Renin plasmatic activity
Renin plasmatic activity will be assessed with ELISA.
Time frame: 20 weeks
Aldosterone
Aldosterone will be assessed with ELISA.
Time frame: 20 weeks
Composite clinical outcome
All-cause mortality or cardiovascular hospitalizations
Time frame: 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.
Time frame: 20 weeks
Estimated glomerular filtration rate
Glomerular filtration rate will be assessed with the CKD-EPI equation.
Time frame: 20 weeks
Plan to share: No — IPD will not be freely available but can be shared to certain investigators.
Ran from Nov 2017 to primary completion in Nov 2019, 23 months.
Of 52 non-industry interventional studies with no phase under Heart Failure, Systolic, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's 23 months is below that.
Counting every sponsor, half of 56 studies reached it within 30 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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