Actively Recruiting
A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure
Led by Tor Biering-Sørensen · Updated on 2025-10-03
4044
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
T
Tor Biering-Sørensen
Lead Sponsor
P
Pharma Nord
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 years or older
- Registered with a heart failure diagnosis as primary discharge diagnosis in The Danish National Patient Registry
- At least one prescription claimed of a renin-angiotensin-system inhibitor and a beta-blocker within 120 days after heart failure diagnosis
- Signed and dated informed consent form
You will not qualify if you...
- Current use of vitamin K-antagonist
- Cancer diagnosis within the last 5 years excluding cutaneous squamous cell or basal cell carcinoma
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Denmark, 2900
Actively Recruiting
Research Team
K
Kristoffer G Skaarup, MD
CONTACT
T
Tor Biering-Sørensen, MD, MPH, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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