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Sodium restriction in patients with chronic heart failure and reduced ejection fraction: A randomized controlled trial
Affiliations- Department of Heart Failure, Hospital de Cardiologia, Centro Medico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico
- Department of Research and Direction, Hospital de Cardiologia, Centro Medico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico
- Department of Echocardiography, Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico
- Department of Laboratory, Hospital de Cardiologia, Centro Medico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico
- Unidad de Investigación Médica en Enfermedades Metabólicas, Hospital de Cardiologia, Centro Medico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico
- Department of Cardiology. Hospital Clinic de Barcelona, Barcelona, Spain
- Department of Nuclear Medicine, Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico
- Head of Cardiology Department, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico City, Mexico
- Directorate of Research, Hospital Infantil de México Federico Gómez, Mexico City, Mexico
- Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut, United States
- Program “A Todo Corazon”, Centro Medico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico
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Abstract
Background: Sodium restriction is recommended for patients with heart failure (HF) despite the lack of solid clinical evidence from randomized controlled trials. Whether or not sodium restrictions provide beneficial cardiac effects is not known. Methods: The present study is a randomized, double-blind, controlled trial of stable HF patients with ejection fraction ≤ 40%. Patients were allocated to sodium restriction (2 g of sodium/day) vs. control (3 g of sodium/day). The primary outcome was change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 20 weeks. Secondary outcomes included quality of life and adverse safety events (HF readmission, blood pressure or electrolyte abnormalities). Results: Seventy patients were enrolled. Median baseline sodium consumption was 3268 (2225–4537) mg/day. Adherence to the intervention based on 24-hour urinary sodium was 32%. NT-proBNP and quality of life did not significantly change between groups (p > 0.05 for both). Adverse safety events were not significantly different between the arms (p > 0.6 for all). In the per protocol analysis, patients who achieved a sodium intake < 2500 mg/day at the intervention conclusion showed improvements in NT-proBNP levels (between-group difference: –55%, 95% confidence interval –27 to –73%; p = 0.002) and quality of life (between-group difference: –11 ± 5 points; p = 0.04). Blood pressure decreased in patients with lower sodium intake (between-group difference: –9 ± 5 mmHg; p = 0.05) without significant differences in symptomatic hypotension or other safety events (p > 0.3 for all). Conclusions: Adherence assessed by 24-hour natriuresis and by the nutritionist was poor. The group allocated to sodium restriction did not show improvement in NT-proBNP. However, patients who achieved a sodium intake < 2500 mg/day appeared to have improvements in NT-proBNP and quality of life without any adverse safety signals. ClinicalTrials.gov Identifier: NCT03351283.
Abstract
Background: Sodium restriction is recommended for patients with heart failure (HF) despite the lack of solid clinical evidence from randomized controlled trials. Whether or not sodium restrictions provide beneficial cardiac effects is not known. Methods: The present study is a randomized, double-blind, controlled trial of stable HF patients with ejection fraction ≤ 40%. Patients were allocated to sodium restriction (2 g of sodium/day) vs. control (3 g of sodium/day). The primary outcome was change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 20 weeks. Secondary outcomes included quality of life and adverse safety events (HF readmission, blood pressure or electrolyte abnormalities). Results: Seventy patients were enrolled. Median baseline sodium consumption was 3268 (2225–4537) mg/day. Adherence to the intervention based on 24-hour urinary sodium was 32%. NT-proBNP and quality of life did not significantly change between groups (p > 0.05 for both). Adverse safety events were not significantly different between the arms (p > 0.6 for all). In the per protocol analysis, patients who achieved a sodium intake < 2500 mg/day at the intervention conclusion showed improvements in NT-proBNP levels (between-group difference: –55%, 95% confidence interval –27 to –73%; p = 0.002) and quality of life (between-group difference: –11 ± 5 points; p = 0.04). Blood pressure decreased in patients with lower sodium intake (between-group difference: –9 ± 5 mmHg; p = 0.05) without significant differences in symptomatic hypotension or other safety events (p > 0.3 for all). Conclusions: Adherence assessed by 24-hour natriuresis and by the nutritionist was poor. The group allocated to sodium restriction did not show improvement in NT-proBNP. However, patients who achieved a sodium intake < 2500 mg/day appeared to have improvements in NT-proBNP and quality of life without any adverse safety signals. ClinicalTrials.gov Identifier: NCT03351283.
Keywords
heart failure, sodium intake, NT-proBNP, quality of life
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About this articleTitle
Sodium restriction in patients with chronic heart failure and reduced ejection fraction: A randomized controlled trial
Journal
Issue
Article type
Original Article
Pages
411-421
Published online
2021-08-26
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3160
Article views/downloads
1017
DOI
Pubmed
Bibliographic record
Cardiol J 2023;30(3):411-421.
Keywords
heart failure
sodium intake
NT-proBNP
quality of life
Authors
Juan B. Ivey-Miranda
Eduardo Almeida-Gutierrez
Raul Herrera-Saucedo
Edith L. Posada-Martinez
Adolfo Chavez-Mendoza
Genaro H. Mendoza-Zavala
Jose A. Cigarroa-Lopez
Jose A. Magaña-Serrano
Roxana Rivera-Leaños
Alberto Treviño-Mejia
Cristina Revilla-Matute
Eduardo J. Flores-Umanzor
Nilda Espinola-Zavaleta
Arturo Orea-Tejeda
Juan Garduño-Espinosa
Guillermo Saturno-Chiu
Veena S. Rao
Jeffrey M. Testani
Gabriela Borrayo-Sanchez
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