Elsevier

American Heart Journal

Volume 169, Issue 2, February 2015, Pages 274-281.e1
American Heart Journal

Clinical Investigations
Heart Failure
The long-term effects of dietary sodium restriction on clinical outcomes in patients with heart failure. The SODIUM-HF (Study of Dietary Intervention Under 100 mmol in Heart Failure): A pilot study

https://doi.org/10.1016/j.ahj.2014.11.013Get rights and content

Aims

To determine the feasibility of conducting a randomized controlled trial comparing a low-sodium to a moderate-sodium diet in heart failure (HF) patients.

Methods and Results

Patients with HF (New York Heart Association classes II-III) were randomized to low (1500 mg/d) or moderate-sodium (2300 mg/d) diet. Dietary intake was evaluated using 3-day food records. The end points were changes in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores and B-type natriuretic peptide (BNP) levels from baseline to 6 months of follow-up presented as medians [25th, 75th percentiles]. Thirty-eight patients were enrolled (19/group). After 6 months, median sodium intake declined from 2137 to 1398 mg/d in the low-sodium and from 2678 to 1461 mg/d in the moderate-sodium diet group. Median BNP levels in the low-sodium diet group declined (216-71 pg/mL, P = .006), whereas in the moderate-sodium diet group, there was no change in BNP (171-188 pg/mL, P = .7; P = .17 between groups). For 6 months, median KCCQ clinical score increased in both groups (63-75 [P = .006] in the low-sodium diet group and 66-73 [P = .07] in the moderate-sodium group; P = .4 between groups). At 6 months, a post hoc analysis based on the dietary sodium intake achieved (> or ≤1500 mg/d) in all patients showed an association between a sodium intake ≤1500 mg/d and improvement in BNP levels and KCCQ scores.

Conclusions

A dietary intervention restricting sodium intake was feasible, and achievement of this sodium goal was associated with lower BNP levels and improved quality of life in patients with HF.

Section snippets

Study design

A pilot, open-label, blinded adjudicated end point, RCT was conducted to evaluate the efficacy of a low-sodium (65 mmol or 1500 mg daily) compared with a moderate-sodium (100 mmol or 2300 mg daily) diet on quality of life and BNP levels after 6 months of follow-up in ambulatory patients with chronic HF.

Patients were included if they were 18 years or older and willing/able to sign informed consent, with confirmed diagnosis of HF (both reduced and preserved systolic function), New York Heart

Results

A total of 451 patients underwent screening between May and December 2012, of which 38 patients were enrolled. Most (63%) of patients screened did not meet the inclusion criteria. Being in NYHA class I or IV was the main reason why patients did not qualify for this study. During follow-up, 2 patients dropped out (one in each group) and 1 died (in the moderate-sodium diet group) (Figure 1). Of the overall study population, 95% (n = 37) was white, 3% (n = 1) was Afro-American, and 3% (n = 1) was

Discussion

Dietary sodium reduction has been proposed and supported by multiple guidelines, yet it is based on little high-quality evidence. In this pilot study, we showed that dietary sodium reduction in HF is feasible when an individualized and structured meal plan with close telephone follow-up is provided to patients.

The median dietary sodium intake at baseline was 2137 and 2678 mg/d in the low- and moderate-sodium group respectively, and it dropped to less than 1500 mg/d after 6 months of dietary

Conclusion

The dietary intervention in this study was feasible and effective in reducing sodium intake in patients with HF. In addition, an achieved sodium intake less than 1500 mg/d was associated with reduced BNP levels, a surrogate prognostic marker, and improved quality of life in ambulatory patients with HF on optimal medical treatment.

Disclosures

The SODIUM-HF Pilot was funded by a University Hospital Foundation (Edmonton, Canada) grant. E.C.R. is funded by a postdoctoral fellowship from Alberta Innovates–Health Solutions (Edmonton, Canada) and the National Council of Science and Technology (CONACYT), Mexico. F.M.A. holds the Capital Health Chair in Cardiology Outcomes Research and an AIHS Senior Health Scholar Award. J.A.E. receives salary support from Alberta Innovates–Health Solutions.

Conflict of interest/disclosures: None declared.

Acknowledgements

We are indebted to the staff and patients of the Heart Function Clinic; Elizabeth Woo, RD; and Quentin Kushnerik, RN, for making this possible.

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