Coenzyme Q10 and selenium supplements for people with heart failure in Denmark

Is this trial a fit for you?

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

What this trial studies

This pragmatic, registry-based, double-blinded, placebo-controlled 2x2 factorial trial will randomize about 4,044 Danish adults with heart failure to coenzyme Q10 versus placebo and selenium versus placebo. The study is event-driven and will use national health registries for identification, follow-up, and primary outcome capture of heart failure hospitalizations and cardiovascular death over an estimated two to three years. Interventions are mailed to participants and no routine in-person visits are required for the main trial, while a substudy of up to 600 participants will attend two clinic visits for echocardiography, blood tests, and a 6-minute walk test at baseline and one year. The pragmatic design leverages existing registry data to measure hard clinical outcomes with minimal participant burden.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals aged ≥ 18 years.
* Registered with a heart failure diagnosis (ICD-10: I50) as a primary discharge diagnosis in The Danish National Patient Registry and at least one claimed prescription of a renin-angiotensin-system inhibitor and a β-blocker within 120 days after HF diagnosis.
* Informed consent form has been signed and dated.

Exclusion Criteria:

* Use of vitamin K-antagonist
* Registered with a cancer diagnosis (C00-C97 not C44) within the last 5 years excluding cutaneous squamous cell or basal cell carcinoma in The Danish National Patient Registry.

Where it's running

• Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
  Hellerup, Denmark Recruiting

Study contacts

• Principal investigator: Tor Biering-Sørensen, MD, MPH, MSc, PhD — Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
• Study coordinator: Kristoffer G Skaarup, MD
• Email: kristoffer.grundtvig.skaarup@regionh.dk
• Phone: +4542451250

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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.