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A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure (DANUTRIO-HF: Q10, DANUTRIO-HF: Selenium)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Heart failure is a common and serious condition. Despite rapid advancements in heart failure treatment, the prognosis remains severe. Smaller studies have shown that two simple, safe, and relatively inexpensive nutritional supplements-coenzyme Q10 and selenium-may reduce the risk of complications associated with heart failure. The DANUTRIO-HF trial will investigate whether these supplements can make a difference for individuals with heart failure. The study will assign approximately 4,044 patients from across Denmark to either coenzyme Q10 (100 mg twice daily) or a corresponding placebo, as well as selenium (100 μg twice daily) or its corresponding placebo, and follow how many of them end up being hospitalized for heart failure or dying from heart problems over an estimated two to three-year period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
RECRUITING
Hellerup
Contact Information
Primary
Kristoffer G Skaarup, MD
kristoffer.grundtvig.skaarup@regionh.dk
+4542451250
Backup
Tor Biering-Sørensen, MD, MPH, MSc, PhD
tor.biering-soerensen@regionh.dk
+4528933590
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 4044
Treatments
Experimental: Coenzyme Q10 intervention, active
100 mg capsules given twice daily, per oral use
Placebo_comparator: Coenzyme Q10 intervention, placebo
Placebo matching coenzyme Q10
Experimental: Selenium intervention, active
100 μg tables given twice daily, per oral use
Placebo_comparator: Selenium intervention, placebo
100 μg tables given twice daily, per oral use
Related Therapeutic Areas
Sponsors
Leads: Tor Biering-Sørensen
Collaborators: Pharma Nord

This content was sourced from clinicaltrials.gov