Effect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure (SODA-HF)
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|ClinicalTrials.gov Identifier: NCT03351283|
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : December 20, 2017
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)
|Condition or disease||Intervention/treatment||Phase|
|Diet, Sodium-Restricted Heart Failure, Systolic Natriuretic Peptide, Brain Clinical Trial||Other: Severe sodium restriction Other: Moderate sodium restriction||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effect of Moderate vs Severe Sodium Restriction on Brain Natriuretic Peptide in Patients With Heart Failure and Reduced Ejection Fraction|
|Actual Study Start Date :||November 22, 2017|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||December 1, 2019|
Experimental: Severe sodium restriction
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 sodium restriction of two grams.
Active Comparator: Moderate 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 three grams.
- Brain natriuretic peptide [ Time Frame: 20 weeks ]Brain natriuretic peptide (NT-proBNP) will be compared at the end of the intervention.
- Quality of life [ Time Frame: 20 weeks ]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 glomerular filtration rate [ Time Frame: 20 weeks ]Measured glomerular filtration rate will be assessed with 24-hour creatinine clearance.
- Renin plasmatic activity [ Time Frame: 20 weeks ]Renin plasmatic activity will be assessed with ELISA.
- Aldosterone [ Time Frame: 20 weeks ]Aldosterone will be assessed with ELISA.
- Composite clinical outcome [ Time Frame: 20 weeks ]All-cause mortality or cardiovascular hospitalizations
- NYHA functional class [ Time Frame: 20 weeks ]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.
- Estimated glomerular filtration rate [ Time Frame: 20 weeks ]Glomerular filtration rate will be assessed with the CKD-EPI equation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351283
|Contact: Juan B Ivey-Miranda, MD||+52 email@example.com|
|Hospital de Cardiología, Centro Médico Nacional Siglo XXI||Recruiting|
|Ciudad de México, Mexico, 06720|
|Contact: Juan B Ivey-Miranda, MD firstname.lastname@example.org|
|Principal Investigator:||Juan B Ivey-Miranda, MD||Instituto Mexicano del Seguro Social|