RecruitingPhase 3NCT07543562

Selenium Intervention Registry Randomized Trial in Heart Failure


Sponsor

Skane University Hospital

Enrollment

4,326 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • To be considered for inclusion in this study, patients must meet all of the following eligibility requirements:
  • 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 Criteria1

  • 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

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Interventions

DIETARY_SUPPLEMENTSelenium Supplement

Selenium 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

DIETARY_SUPPLEMENTPlacebo

Placebo tablet identical to active comparator


Locations(11)

Oslo University Hospital

Oslo, Norway

Skånes University Hospital

Malmö, Skåne County, Sweden

Sahlgrenska University Hospital Östra

Gothenburg, Sweden

Sahlgrenska

Gothenburg, Sweden

Ryhov Hospital

Jönköping, Sweden

Linköping University Hospital

Linköping, Sweden

Skånes University Hospital

Lund, Sweden

Örebro University Hospital

Örebro, Sweden

Karolinska University Hospital

Stockholm, Sweden

Norrlands university Hospital

Umeå, Sweden

Akademiska University hospital

Uppsala, Sweden

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NCT07543562


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