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

IF 2.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Cardiology journal Pub Date : 2023-01-01 Epub Date: 2021-09-07 DOI:10.5603/CJ.a2021.0098

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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引用次数: 3

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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查看原文本刊更多论文

慢性心力衰竭和射血分数降低患者的钠限制：一项随机对照试验。

背景：尽管缺乏来自随机对照试验的可靠临床证据，但建议心力衰竭患者限制钠摄入。限制钠摄入是否能对心脏产生有益影响尚不清楚。方法：本研究是一项随机、双盲、对照试验，研究对象为射血分数≤40%的稳定型心衰患者。患者被分配到钠限制（2克钠/天）与对照（3克钠/日）。主要结果是20周时N-末端B型钠尿肽原（NT-proBNP）的变化。次要结果包括生活质量和不良安全事件（HF再入院、血压或电解质异常）。结果：70名患者入选。中位基线钠消耗量为3268（2225-4537）mg/天。基于24小时尿钠的干预依从性为32%。NT-proBNP和生活质量在两组之间没有显著变化（两组均p>0.05）。不良安全性事件在两组之间没有显著差异（所有组均p>0.05）。在按协议分析中，干预结束时钠摄入量<2500 mg/天的患者NT-proBNP水平（组间差异：-55%，95%置信区间-27-73%；p=0.002）和生活质量（组间差：-11±5分；p=0.04）均有改善。钠摄入量较低的患者血压下降（组间差值：-9±5 mmHg；p=0.05）在症状性低血压或其他安全事件方面没有显著差异（所有患者的p＞0.3）。结论：24小时钠尿和营养学家评估的依从性较差。钠限制组的NT-proBNP没有改善。然而，钠摄入量<2500 mg/天的患者似乎在NT-proBNP和生活质量方面有所改善，没有任何不良安全信号。Clinicaltrials:gov标识符：NCT03351283。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cardiology journal CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

5.10

自引率

10.30%

发文量

188

审稿时长

4-8 weeks

期刊介绍： Cardiology Journal is a scientific, peer-reviewed journal covering a broad spectrum of topics in cardiology. The journal has been published since 1994 and over the years it has become an internationally recognized journal of cardiological and medical community. Cardiology Journal is the journal for practicing cardiologists, researchers, and young trainees benefiting from broad spectrum of useful educational content.