Selenium Intervention Registry Randomized Trial in Heart Failure

Summary

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.

Eligibility

Inclusion Criteria:

To be considered for inclusion in this study, patients must meet all of the following eligibility requirements:

* 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.

Exclusion Criteria:

* 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

Conditions8

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