Selenium Intervention Registry Randomized Trial in Heart Failure

What this Trial Is About

Heart failure is a serious condition where the heart cannot pump blood effectively, leading to high rates of hospitalization and death globally. This research aims to evaluate whether adding daily selenium supplementation to standard heart failure treatment can improve patient outcomes. Selenium is a vital micronutrient involved in energy production and heart function, and low selenium levels are common among heart failure patients in Northern Europe. The study addresses a gap in knowledge about whether selenium supplements can reduce hospitalizations and cardiovascular deaths in these patients. Participants will be randomly assigned to receive either 200 micrograms of selenium daily as a Bio-SelenoPrecise supplement or a matching placebo, alongside guideline-directed medical therapy. The trial is double-blind and will recruit about 4,326 adults diagnosed with heart failure. Recruitment will last approximately four years, followed by an additional year of observation, resulting in about three years of follow-up on average. The study uses a registry-based approach in Sweden and Norway, allowing remote enrollment and follow-up through questionnaires and national health registries. During the study, participants will complete electronic surveys on symptoms, adherence, and quality of life, while clinical events like hospitalizations and deaths will be monitored through national registries. The main outcome measured is the total number of heart failure hospitalizations and cardiovascular deaths. Secondary outcomes include all-cause mortality, symptom changes, and safety. A mechanistic sub-study will explore selenium's effects on heart structure and function in a subset of participants. The trial's design aims to provide real-world evidence on selenium supplementation in heart failure management.

Selenium Intervention Registry Randomized Trial in Heart Failure