A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure
Recruiting · NCT06694727 · Interventional (participants receive a specific treatment) · Lead sponsor: Tor Biering-Sørensen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte - Hellerup, Denmark