Selenium Intervention Registry Randomized Trial in Heart Failure

NCT07543562 | Recruiting Phase 3

• 1 other identifier: Dnr 2025-02943-01
• Study Type: interventional
• Target: 4,326
• Locations: 2 countries
• Sites: 11

Brief 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

Keywords

heart failure; selenium; RRCT; SIRI-HF

Outcome Measures

Primary Outcomes (1)

• Number of HF hospitalizations and/or CV mortality in heart failure patients.

  The primary objective is to assess whether supplementation with selenium compared to placebo reduces the number of HF hospitalizations and/or CV mortality in HF patients.

  Recruitment over 4 years, followed by an additional year of observation, resulting in an average follow-up of 3 years, with an adaptive component allowing for an interim analysis to evaluate accrued data and adjust the study duration if necessary

Secondary Outcomes (2)

• Number of major adverse cardiovascular events

  Recruitment over 4 years, followed by an additional year of observation, resulting in an average follow-up of 3 years, with an adaptive component allowing for an interim analysis to evaluate accrued data and adjust study duration if necessary.

• Time to a composite event of first hospitalization for HF or CV death

  Recruitment over 4 years, followed by an additional year of observation, resulting in an average follow-up of 3 years, with an adaptive component allowing for an interim analysis to evaluate accrued data and adjust the study duration if necessary

Study Arms (2)

Selenium 200mcg daily in addition to GDMT

ACTIVE COMPARATOR

Dietary Supplement: Selenium Supplement

Placebo in addition to GDMT

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Selenium Supplement DIETARY_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

Selenium 200mcg daily in addition to GDMT

Placebo DIETARY_SUPPLEMENT

Placebo tablet identical to active comparator

Placebo in addition to GDMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Skane University Hospital: lead
• Uppsala Clinical Research Center, Sweden: collaborator

Study Sites (11)

Oslo University Hospital

Oslo, Norway

RECRUITING

Skånes University Hospital

Malmo, Skåne County, Sweden

RECRUITING

Sahlgrenska University Hospital Östra

Gothenburg, Sweden

RECRUITING

Sahlgrenska

Gothenburg, Sweden

RECRUITING

Ryhov Hospital

Jönköping, Sweden

RECRUITING

Linköping University Hospital

Linköping, Sweden

RECRUITING

Skånes University Hospital

Lund, Sweden

RECRUITING

Örebro University Hospital

Örebro, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Norrlands university Hospital

Umeå, Sweden

RECRUITING

Akademiska University hospital

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Martin Magnusson, Professor

CONTACT

+46186119515; siri_hf@ucr.uu.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: This study is an investigator-initiated, pragmatic, double-blinded, placebo-controlled, randomized trial, designed to evaluate the effects of selenium versus placebo in reducing the composite of number of HF hospitalizations and/or CV death among patients with HF. The trial will employ a registry-based approach to maximize efficiency and relevance to real-world settings. A number of 4326 participants will be randomized in 1:1 fashion (2163 per arm). Eligible participants will be identified through the SwedeHF Registry, which will also serve as a primary tool for data collection, alongside the Swedish National Board of Health and Welfare and National Cause of Death Register in Sweden. In Norway, NHFR will be used to recruit patients and Helsedirektoratet will be used to retrieve follow-up data. These registries will capture essential baseline information and follow-up data throughout the study.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

NO (1); SE (10)