Heterogeneity in Treatment Effects in the SODIUM-HF Trial

The SODIUM-HF trial investigated if a low-sodium diet improved outcomes for heart failure (HF) patients more than a typical diet, ultimately finding no overall advantage. A recent secondary analysis of the study data was conducted to determine if certain patients benefited from this dietary intervention while others did not.

Using a risk-based approach, researchers stratified patients into four groups based on their risk of adverse cardiac events. The analysis revealed that a low-sodium diet may benefit patients in the lower-risk group, while potentially causing harm to those in the highest-risk group. A specialized statistical method provided evidence for this finding of heterogeneity in treatment effects (HTE).

The study results indicate that a “one-size-fits-all” approach to dietary sodium restriction for HF patients may be ineffective. Instead, a patient’s individual risk profile should be considered. To better personalize care, the researchers recommend that future trials incorporate an analysis of HTE from the outset, which would help to design more effective studies and create better-tailored dietary interventions for patients.

This research was led by Fernando Zampieri, MD, PhD (University of Alberta) and co-authored by the CVC’s Justin Ezekowitz, MBBCh, MSc, Sarah Rathwell, MSc, Finlay McAlister, MD, MSc, and Wendimagegn Alemayehu, PhD. Additional collaborators were Heather Ross, MD, MHSc (Peter Munk Cardiac Centre), Jorge Escobedo, MD (Instituto Mexicano del Seguro Social), Clara Saldarriaga, MD (Centro Cardiovascular Colombiano Clinica Santa Maria), Eloisa Colin-Ramirez, PhD (Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán), Richard Troughton, MBChB (University of Otago), and Peter Macdonald, MD (St Vincent’s Hospital Sydney).