Clinical InvestigationsHeart FailureThe 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
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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Clinical Trial Identifier: Clinicaltrials.gov Identifier: NCT01480401.