Clinical trial Recruiting at 11 sites Phase 3 Interventional Ages 18 and up

Selenium supplementation for people with heart failure

Official title: Selenium Intervention Registry Randomized Trial in Heart Failure

Run by Skane University Hospital · NCT07543562 · Data updated 2026-11-12

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment4326 (estimated)
SponsorSkane University Hospital
Academic / other
Locations11 sites (Oslo and 10 other locations)
StatusRecruiting
StartedApril 1, 2026
Main results expectedMarch 2030
Study endsMarch 2031
Registry record updatedApril 22, 2026
Trial IDNCT07543562 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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
Show 5 more locations
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.