Heart failure is a serious condition in which the heart is unable to pump blood effectively, and it remains a leading cause of hospitalization and death worldwide despite advances in treatment.
Selenium is an essential micronutrient that plays an important role in cellular energy production, antioxidant defense, and overall cardiovascular function. Low selenium levels are common among patients with heart failure in Northern Europe, and observational studies have shown that selenium deficiency is associated with an increased risk of hospitalization and death. In cases of severe deficiency, such as in Keshan disease, heart dysfunction can be reversed with selenium supplementation, suggesting a potential causal relationship.
However, it is not yet known whether selenium supplementation can improve clinical outcomes in patients with heart failure when added to standard medical therapy.
The SIRI-HF trial is a randomized, placebo-controlled study designed to evaluate whether daily supplementation with 200 micrograms of selenium, in addition to guideline-directed medical therapy, improves outcomes in patients with heart failure.
The primary endpoint is a composite of recurrent heart failure hospitalizations and cardiovascular death. Secondary endpoints include all-cause mortality, changes in symptoms and functional status, and safety outcomes.
This study will include patients from Sweden and Norway and aims to determine whether correcting selenium deficiency can improve prognosis in heart failure.
18 years of age
primary discharge diagnosis of HF coded as ICD-10: I50, as recorded in The SwedeHF registry
be able to provide documented informed consent by signing and dating the designated consent form.
Not suitable in the opinion of the Investigator (for example due to severe or terminal comorbidity with poor prognosis, or characteristics, pregnancy etc.) that may interfere with adherence to trial protocol
Parallel
Selenium Supplement
Dietary supplementSelenium will be provided as the Bio-SelenoPrecise supplement. Each Bio-SelenoPrecise tablet contains 200 μg of selenium in the form of the yeast-based compound SelenoPrecise yeast. The tablets also include excipients such as microcrystalline cellulose, dicalcium phosphate, crosscarmellose sodium, silica, magnesium stearate, and is coated with hydroxypropyl methylcellulose
Placebo
Dietary supplementPlacebo tablet identical to active comparator
Number of HF hospitalizations and/or CV mortality in heart failure patients.
The primary objective is to assess whether supplementation with selenium compared to placebo reduces the number of HF hospitalizations and/or CV mortality in HF patients.
Number of major adverse cardiovascular events
\- Major adverse CV events (MACE), defined as a combination of hospitalization for HF, stroke, acute myocardial infarction, or CV death.
Time to a composite event of first hospitalization for HF or CV death
Secondary objectives of the study are (i) time to a composite event of first hospitalization for HF or CV death, both defined as in the primary endpoint,
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Skane University Hospital
Lead sponsor
Uppsala University
Collaborator
