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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
Sponsor:
Information provided by (Responsible Party):
Eduardo Almeida Gutiérrez, Instituto Mexicano del Seguro Social

Brief 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%).

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Brain natriuretic peptide [ Time Frame: 20 weeks ]
    Brain natriuretic peptide (NT-proBNP) will be compared at the end of the intervention.


Secondary Outcome Measures :
  1. 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.

  2. Measured glomerular filtration rate [ Time Frame: 20 weeks ]
    Measured glomerular filtration rate will be assessed with 24-hour creatinine clearance.

  3. Renin plasmatic activity [ Time Frame: 20 weeks ]
    Renin plasmatic activity will be assessed with ELISA.

  4. Aldosterone [ Time Frame: 20 weeks ]
    Aldosterone will be assessed with ELISA.

  5. Composite clinical outcome [ Time Frame: 20 weeks ]
    All-cause mortality or cardiovascular hospitalizations

  6. 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.


Other Outcome Measures:
  1. Estimated glomerular filtration rate [ Time Frame: 20 weeks ]
    Glomerular filtration rate will be assessed with the CKD-EPI equation.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with a diagnosis of stable heart failure and decreased left ventricular ejection fraction. Such definition will contemplate the following:

  1. Patients should have an echocardiogram of maximum 6 months old with a left ventricular ejection fraction of less than 40%.
  2. Functional class I, II or III of the NYHA
  3. 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.
  4. No changes in pharmacological treatment in the last 4 weeks.
  5. Systolic blood pressure greater than or equal to 90 mmHg.
  6. Informed consent to participate in the study.

Exclusion Criteria:

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.


Information from the National Library of Medicine

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


Contacts
Contact: Juan B Ivey-Miranda, MD +52 96888805 betuel.ivey@gmail.com

Locations
Mexico
Hospital de Cardiología, Centro Médico Nacional Siglo XXI Recruiting
Ciudad de México, Mexico, 06720
Contact: Juan B Ivey-Miranda, MD       betuel.ivey@gmail.com   
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Juan B Ivey-Miranda, MD Instituto Mexicano del Seguro Social

Responsible Party: Eduardo Almeida Gutiérrez, Dr, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT03351283     History of Changes
Other Study ID Numbers: Sodium and BNP
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs