Status:
COMPLETED
Effect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure
Lead Sponsor:
Instituto Mexicano del Seguro Social
Conditions:
Diet, Sodium-Restricted
Heart Failure, Systolic
Eligibility:
All Genders
18+ years
Phase:
NA
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 reduce...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03351283
Start Date
November 22 2017
End Date
August 1 2020
Last Update
September 9 2020
Active Locations (1)
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1
Hospital de Cardiología, Centro Médico Nacional Siglo XXI
Mexico City, Mexico, 06720