Coenzyme Q10 and selenium supplements for people with heart failure in Denmark
A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure (DANUTRIO-HF: Q10, DANUTRIO-HF: Selenium)
This trial will test whether taking daily coenzyme Q10 and selenium supplements helps people with heart failure avoid hospital stays or dying from heart-related causes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 4044 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Hellerup) |
| Trial ID | NCT06694727 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults in Denmark with a registered heart failure diagnosis who have filled prescriptions for a renin-angiotensin system inhibitor and a β-blocker and can provide informed consent are the intended participants.
Not a fit: Patients taking vitamin K antagonists or those with a cancer diagnosis in the past five years (excluding certain non-melanoma skin cancers) are excluded and would not receive benefit from participation.
Why it matters
Potential benefit: If effective, these low-cost, widely available supplements could reduce heart failure hospitalizations and heart-related deaths.
How similar studies have performed: Smaller randomized trials and observational studies have suggested potential benefit from coenzyme Q10 in heart failure, but large, definitive randomized evidence—particularly for selenium or combined supplementation—is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hellerup
- 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
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.