Design and Region-Specific Adaptation of the Dietary Intervention Used in the SODIUM-HF Trial: A Multicentre Study.

Background: Restricting dietary sodium consumption has been considered a major component of self-care management in heart failure (HF); however, the evidence supporting this recommendation has not been conclusive. The S tudy o f D ietary I ntervention U nder 100 M MOL in H eart F ailure (SODIUM-HF) trial aims to assess the effects of dietary sodium reduction on clinical outcomes in a HF population using a pragmatic design to provide empirical evidence to guide dietary sodium intake recommendations in patients with chronic HF.

Methods: SODIUM-HF is a multicentre, open-label, blinded adjudicated endpoint, randomized controlled trial in ambulatory patients with chronic HF. This trial involves participants recruited from sites in Canada, Australia, New Zealand, Mexico, Colombia, and Chile, who are followed up to 24 months. Rationale and methods of the SODIUM-HF trial were published elsewhere. As an international pragmatic dietary trial, SODIUM-HF was designed to address several challenges, such as defining the most suitable intervention to account for country-specific variations in food intake and availability. In SODIUM-HF, we implemented the Nutrition-Care Model to provide a comprehensive intervention delivered directly to patients, focusing on modifying the nutrient composition of the diet (sodium restriction), using a personalized counselling and close follow-up.

Results: Available upon completion of the trial.

Conclusions: This long-term dietary trial is one of the first in its type in the HF field. This article describes in detail the rationale and methods for the dietary intervention employed and the region-specific adaptation of the SODIUM-HF intervention, so that the learning and processes taken in this trial can be applied to future multicountry dietary clinical trials.