September 7, 2021Open Access

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

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Chronic heart failure with reduced ejection fraction (n=70). Intervention: Sodium restriction vs. Control group (3 g of sodium/day). Primary outcome: Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 20 weeks (null, 95% CI null, p=0.88).

JIJuan B. Ivey‐MirandaHeart Failure & Transplant EAEduardo Almeida‐GutiérrezCentro Medico Nacional Siglo XXI RHRaúl Herrera-SaucedoMexican Social Security Institute

Key Result

Patients who achieved a sodium intake < 2500 mg/day showed improvements in NT-proBNP levels by 55% and quality of life by 11 ± 5 points compared to those with higher sodium intake.

Study Design

Type

RCT (n=70)

Blinding

Double-blind

Randomization

Simple sequential randomization

Multicenter

PICO

Population

Chronic heart failure with reduced ejection fraction (n=70)

Intervention / Comparator

Sodium restriction vs Control group (3 g of sodium/day) (2 g of sodium/day)

Primary Outcome

Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 20 weeks — null (null), p=0.88

Main Result

Effect estimate: null (95% CI null)

Absolute Event Rate: 882% vs 569%

p-value: p=0.88

Limitations

Relative small sample size, thus results should be interpreted cautiously.
Baseline sodium intake was not excessively high; therefore, results may not extrapolate to patients with higher sodium intake.
Adherence was assessed only four times during the 20-week period, which may not accurately reflect dietary changes.

Abstract

gov Identifier: NCT03351283.

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