MedicalResearch.com Interview with:
Dr. Eloisa Colin-Ramirez, BSc, PhD and
Justin A. Ezekowitz, MBBCh MSc
Associate Professor, University of Alberta
Co-Director, Canadian VIGOUR Centre
Director, Heart Function Clinic
Cardiologist, Mazankowski Alberta Heart Institute
Medical Research: What is the background for this study? What are the main findings?
Response: The SODIUM-HF study is a randomized control trial on sodium restriction in patients with chronic heart failure (HF). Sodium restriction has been broadly recommended as part of the self-care strategies in heart failure yet is based on little high-quality evidence. This study reports the results of the pilot SODIUM-HF trial in 38 patients with chronic HF. Nineteen patients were prescribed a low sodium containing diet (1500 mg/day) and 19 a moderate sodium containing diet (2300 mg/day). Both interventions were based on a structured and individualized meal plan to achieve the targeted sodium intake, and all patients were followed for 6 months with monthly phone call to reinforce adherence to the diet.
We found a meaningful reduction in sodium intake to less than 1500 mg/day at 6 months in both groups. Additionally, we observed that patients that achieved a sodium intake less than 1500 mg/day at 6 months of follow-up had reduced BNP levels, a biomarker of volume overload and surrogate prognostic marker in heart failure, and increased overall and clinical scores of the Kansas City Cardiomyopathy Questionnaire, compared to those with a sodium intake greater than 1500 mg/day.
Medical Research: What should clinicians and patients take away from your report?
- First, results of this pilot study suggest that dietary sodium reduction in heart failure is feasible when an individualized and structured meal plan with close follow-up is provided to patients.
- Secondly, an achieved sodium intake less than 1500 mg/day at 6 months of follow-up was associated with reduced BNP levels and improved quality of life in ambulatory patients with heart failure on optimal medical treatment. However, larger RCTs with clinical outcomes as primary endpoints are required to support this recommendation and confirm a better prognosis associated to less sodium intake in patients with HF.
Medical Research: What recommendations do you have for future research as a result of this study?
Response: Currently, the SODIUM-HF trial (SODIUM-HF; clinicaltrials.gov NCT02012179) is being conducted. In order to ensure the intervention leads to a more meaningful differences in sodium intake between groups, this multicentre trial is employing the same dietary strategies used in this pilot to counsel patients in the low-sodium diet group; however, the Usual Care group is receiving usual dietary recommendation for sodium restriction and follow-up as provided during routine clinical practice and supported by the Canadian heart failure guidelines. This ongoing multicenter trial is expected to provide definite results on the effects of sodium restriction in HF patients and develop evidence-based guideline for sodium restriction in this patient population.