Actively Recruiting
A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure (DANUTRIO-HF: Q10, DANUTRIO-HF: Selenium)
Led by Tor Biering-Sørensen · Updated on 2025-10-03
4044
Participants Needed
1
Research Sites
26 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 with a severe prognosis despite advances in treatment. Researchers are evaluating whether two nutritional supplements, coenzyme Q10 and selenium, can reduce complications such as hospitalization for heart failure or death from heart problems. This is a pragmatic, double-blinded, placebo-controlled, randomized trial involving about 4,044 participants in Denmark. Participants will be randomly assigned to four groups receiving either coenzyme Q10 (100 mg twice daily), selenium (100 micrograms twice daily), both supplements, or matching placebos. The main study is conducted remotely using Danish health registries for data collection, with study treatments mailed directly to participants. A substudy including up to 600 participants involves two in-person visits for additional assessments such as echocardiography, blood tests, and a 6-minute walk test at baseline and after one year. During the study, researchers will monitor hospitalizations for heart failure and cardiovascular deaths over about two to three years. The substudy will also evaluate participants' functional capacity, treatment adherence, biomarkers, and heart function and structure. There are no scheduled visits for the main trial, and all outcome data are collected through registries. Safety and treatment effects will be assessed throughout the estimated 33-month study period.
CONDITIONS
Brief 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
- At least one prescription 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...
- Use of vitamin K-antagonist medication
- Cancer diagnosis within the last 5 years excluding cutaneous squamous cell or basal cell carcinoma
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote screening via Danish electronic letter system)
Duration - Up to approximately 33 months
Participants take daily nutritional supplements of coenzyme Q10 and/or selenium or matching placebos to evaluate effects on heart failure outcomes.
Supplements are mailed to participants; no scheduled in-person visits for the main study
Duration - 1 year
A subset of participants attend two in-person visits for additional testing including echocardiography, blood sampling, and a 6-minute walk test at baseline and 1-year follow-up.
2 visits (in-person) for substudy assessments
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
T
Tor Biering-Sørensen, MD, MPH, MSc, PhD
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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