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.

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

DIETARY_SUPPLEMENT

Selenium 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_SUPPLEMENT

Placebo

Placebo tablet identical to active comparator

Sponsors & Collaborators

• Uppsala Clinical Research Center, Sweden

  collaborator UNKNOWN

• Skane University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2030-03-31

Completion

2031-03-31

Countries

• Norway
• Sweden

Study Locations