A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure DANUTRIO-HF Q10, DANUTRIO-HF Selenium

What this Trial Is About

Heart failure is a common and serious condition with a severe prognosis despite advances in treatment. Researchers are evaluating whether two nutritional supplements, coenzyme Q10 and selenium, can reduce complications such as hospitalization for heart failure or death from heart problems. This is a pragmatic, double-blinded, placebo-controlled, randomized trial involving about 4,044 participants in Denmark. Participants will be randomly assigned to four groups receiving either coenzyme Q10 100 mg twice daily, selenium 100 micrograms twice daily, both supplements, or matching placebos. The main study is conducted remotely using Danish health registries for data collection, with study treatments mailed directly to participants. A substudy including up to 600 participants involves two in-person visits for additional assessments such as echocardiography, blood tests, and a 6-minute walk test at baseline and after one year. During the study, researchers will monitor hospitalizations for heart failure and cardiovascular deaths over about two to three years. The substudy will also evaluate participants functional capacity, treatment adherence, biomarkers, and heart function and structure. There are no scheduled visits for the main trial, and all outcome data are collected through registries. Safety and treatment effects will be assessed throughout the estimated 33-month study period.

A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure