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NCT07543562RecruitingPhase 3

Selenium Intervention Registry Randomized Trial in Heart Failure

Source: ClinicalTrials.gov · Last updated 22 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
4326 (estimated)
First submitted
7 Apr 2026
Start date
1 Apr 2026
Primary completion date
31 Mar 2030
Lead sponsor
Skane University Hospital
NCT number
NCT07543562

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 4326
  • From 1 Apr 2026 to the primary completion date, 31 Mar 2030
  • 11 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oslo University Hospital
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OsloNorwayRecruiting
Sahlgrenska
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GothenburgSwedenRecruiting
Sahlgrenska University Hospital/Östra
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GothenburgSwedenRecruiting
Ryhov Hospital
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JönköpingSwedenRecruiting
Linkoping University Hospital
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LinköpingSwedenRecruiting
Skånes University Hospital
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LundSwedenRecruiting
Skånes University Hospital
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MalmöSwedenRecruiting
Örebro University Hospital
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ÖrebroSwedenRecruiting
Karolinska University Hospital
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StockholmSwedenRecruiting
Norrlands University Hospital
Coordinator of this site? Confirm its status
UmeåSwedenRecruiting
Akademiska University Hospital
Coordinator of this site? Confirm its status
UppsalaSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.