Effect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure

NCT03351283 | Completed

• 1 other identifier: Sodium and BNP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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)

Conditions

Diet, Sodium-Restricted; Heart Failure, Systolic; Natriuretic Peptide, Brain; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Brain natriuretic peptide

  Brain natriuretic peptide (NT-proBNP) will be compared at the end of the intervention.

  20 weeks

Secondary Outcomes (6)

• Improvement in Quality of life

  20 weeks

• Measured glomerular filtration rate

  20 weeks

• Renin plasmatic activity

  20 weeks

• Aldosterone

  20 weeks

• Composite clinical outcome

  20 weeks

Other Outcomes (1)

• Estimated glomerular filtration rate

  20 weeks

Study Arms (2)

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.

Other: Severe sodium restriction

Moderate sodium restriction.

ACTIVE COMPARATOR

Patients will be assigned to a diet with three grams of sodium.

Other: Moderate sodium restriction

Interventions

Severe sodium restriction OTHER

Patients will be assigned to a diet with sodium restriction of two grams.

Severe sodium restriction

Moderate sodium restriction OTHER

Patients will be assigned to a diet with sodium restriction of three grams.

Moderate sodium restriction.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Hospital de Cardiología, Centro Médico Nacional Siglo XXI

Mexico City, 06720, Mexico

Location

Related Publications (1)

• 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.

  PMID: 34490604 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Juan B Ivey-Miranda, MD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 22, 2017
• Study Start: November 22, 2017
• Primary Completion: November 1, 2019
• Study Completion: August 1, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)