Project Title

Nutritional Supplements in Heart Failure

Background

Heart failure remains a major health challenge with high mortality and frequent hospitalizations. Despite advancements in treatment, residual risk persists. Coenzyme Q10 and selenium have gained attention as potential therapeutic candidates, as nutrient deficiencies are common in heart failure and may contribute to clinical deterioration by impairing cardiac cell function. However, robust evidence from large, randomized trials is lacking.

Aim

The project will be carried out through a pragmatic randomized controlled trial, the DANUTRIO-HF trial, which aims to randomize 4,044 participants. The primary objective is to assess whether coenzyme Q10 and selenium supplementation reduces heart failure hospitalization and/or cardiovascular death. A sub-study of 600 participants aims to evaluate the potential effects of coenzyme Q10 and selenium on functional capacity, biomarkers, and cardiac structure and function.

Methods

Eligible participants will be randomly assigned either to coenzyme Q10 vs. placebo and to selenium vs. placebo (≈25% will receive coenzyme Q10 + placebo, ≈25% selenium + placebo, ≈25% coenzyme Q10 + selenium, and ≈25% placebo + placebo). Study interventions will be mailed to participants and data collection will rely on Danish national health registries, eliminating the need for in-person visits in the main trial.