NCT06694727 A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure
| NCT ID | NCT06694727 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tor Biering-Sørensen |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,044 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 4,044 participants in total. It began in 2025-09-30 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Tor Biering-Sørensen, MD, MPH, MSc, PhD
PRINCIPAL INVESTIGATOR
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Frequently Asked Questions
Who can join the NCT06694727 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06694727 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 4,044 participants.
Is NCT06694727 currently recruiting?
Yes, NCT06694727 is actively recruiting participants. Contact the research team at kristoffer.grundtvig.skaarup@regionh.dk for enrollment information.
Where is the NCT06694727 trial being conducted?
This trial is being conducted at Hellerup, Denmark.
Who is sponsoring the NCT06694727 clinical trial?
NCT06694727 is sponsored by Tor Biering-Sørensen. The principal investigator is Tor Biering-Sørensen, MD, MPH, MSc, PhD at Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte. The trial plans to enroll 4,044 participants.
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