NCT07543562 Selenium Heart Failure Phase 3 Trial
Summary
The SIRI-HF trial (NCT07543562) is a randomized, placebo-controlled Phase 3 clinical study evaluating whether daily supplementation with 200 micrograms of selenium, added to guideline-directed medical therapy, improves outcomes in heart failure patients. The primary endpoint is a composite of recurrent heart failure hospitalizations and cardiovascular death, with secondary endpoints including all-cause mortality, symptom and functional status changes, and safety outcomes. The trial will enroll patients from Sweden and Norway to determine whether correcting selenium deficiency improves prognosis in heart failure.
“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.”
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What changed
The SIRI-HF trial registered on ClinicalTrials.gov represents a new Phase 3 clinical investigation of selenium supplementation in heart failure. The trial will randomize patients to receive either 200 micrograms of selenium daily or placebo, alongside standard medical therapy, to evaluate whether correcting selenium deficiency reduces recurrent hospitalizations and cardiovascular death. Key inclusion criteria span heart failure with reduced, mildly reduced, and preserved ejection fraction.
For clinical operations and research teams, this trial registration signals an active Phase 3 investigation in the cardiovascular nutraceutical space with enrollment in Nordic European sites. Sponsors and clinical sites should ensure compliance with Good Clinical Practice standards for Phase 3 pharmaceutical investigations. Researchers studying micronutrient interventions in cardiovascular disease may find the trial design and endpoints relevant for comparative analysis.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Selenium Intervention Registry Randomized Trial in Heart Failure
Phase 3 NCT07543562 Kind: PHASE3 Apr 22, 2026
Abstract
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 prog...
Conditions: Heart Failure, Heart Failure and Reduced Ejection Fraction, Heart Failure and Mildly Reduced Ejection Fraction, Heart Failure and Preserved Ejection Fraction, Selenium Supplementation, Selenium, Cognitive Functioning
Interventions: Selenium Supplement, Placebo
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