Selenium supplementation for people with heart failure
Selenium Intervention Registry Randomized Trial in Heart Failure
This trial will test whether taking a daily selenium supplement helps people with heart failure avoid hospitalization and reduce the risk of death.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 4326 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Skane University Hospital Academic / other |
| Locations | 11 sites (Oslo and 10 other locations) |
| Trial ID | NCT07543562 on ClinicalTrials.gov |
What this trial studies
SIRI-HF is a randomized, placebo-controlled, registry-based trial enrolling adults with a primary discharge diagnosis of heart failure recorded in the SwedeHF registry. Participants are randomized to receive daily selenium supplementation or matching placebo in addition to standard medical therapy and are followed for clinical events such as hospitalizations, mortality, and functional outcomes. The pragmatic RRCT design leverages existing registry infrastructure to streamline enrollment and outcome capture across academic hospitals in Sweden and Norway. The trial targets populations in Northern Europe where low selenium status is common to see if correcting deficiency improves cardiac function and clinical endpoints.
Who should consider this trial
Good fit: Ideal candidates are adults with a primary hospital discharge diagnosis of heart failure who are enrolled in the SwedeHF registry and can give informed consent.
Not a fit: Patients with normal or high selenium levels, non-cardiac causes of symptoms, or severe terminal comorbidities are less likely to benefit from selenium supplementation.
Why it matters
Potential benefit: If successful, this could provide a low-cost, widely accessible supplement that reduces hospitalizations and deaths among people with heart failure.
How similar studies have performed: Prior randomized trials have shown mixed results and often included populations with adequate selenium, though observational data and treatment of severe deficiency (e.g., Keshan disease) suggest potential benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: * 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
Where this trial is running
Oslo and 10 other locations
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Skånes University Hospital — Malmö, 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)
Study contacts
- Study coordinator: Martin Magnusson, Professor
- Email: siri_hf@ucr.uu.se
- Phone: +46186119515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.