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Sodium restriction in patients with chronic heart failure and reduced ejection fraction: A randomized controlled trial

Juan Betuel Ivey-Miranda, Eduardo Almeida-Gutierrez, Raul Herrera-Saucedo, Edith Liliana Posada-Martinez, Adolfo Chavez-Mendoza, Genaro Hiram Mendoza-Zavala, Jose Angel Cigarroa-Lopez, Jose Antonio Magaña-Serrano, Roxana Rivera-Leaños, Alberto Treviño-Mejia, Cristina Revilla-Matute, Eduardo Josue Flores-Umanzor, Nilda Espinola-Zavaleta, Arturo Orea-Tejeda, Juan Garduño-Espinosa, Guillermo Saturno-Chiu, Veena S Rao, Jeffrey Moore Testani, Gabriela Borrayo-Sanchez
DOI: 10.5603/CJ.a2021.0098
·
Pubmed: 34490604

open access

Ahead of print
Original articles
Published online: 2021-08-26

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.

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Keywords

heart failure, sodium intake, NT-proBNP, quality of life

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Title

Sodium restriction in patients with chronic heart failure and reduced ejection fraction: A randomized controlled trial

Journal

Cardiology Journal

Issue

Ahead of print

Article type

Original Article

Published online

2021-08-26

DOI

10.5603/CJ.a2021.0098

Pubmed

34490604

Keywords

heart failure
sodium intake
NT-proBNP
quality of life

Authors

Juan Betuel Ivey-Miranda
Eduardo Almeida-Gutierrez
Raul Herrera-Saucedo
Edith Liliana Posada-Martinez
Adolfo Chavez-Mendoza
Genaro Hiram Mendoza-Zavala
Jose Angel Cigarroa-Lopez
Jose Antonio Magaña-Serrano
Roxana Rivera-Leaños
Alberto Treviño-Mejia
Cristina Revilla-Matute
Eduardo Josue Flores-Umanzor
Nilda Espinola-Zavaleta
Arturo Orea-Tejeda
Juan Garduño-Espinosa
Guillermo Saturno-Chiu
Veena S Rao
Jeffrey Moore Testani
Gabriela Borrayo-Sanchez

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