A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure

NCT ID: NCT06694727

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 4044 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2029-06-01

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.

Detailed Description

This investigator-initiated, pragmatic, registry-based, double-blinded, placebo-controlled, 2x2 factorial, individually randomized trial aims to evaluate the efficacy of daily intake of the nutritional supplements coenzyme Q10 versus placebo, and selenium versus placebo, in preventing heart failure hospitalizations and cardiovascular death in heart failure patients. The trial plans to randomize approximately 4,044 participants in an event-driven design. Participants will be identified through the Danish Administrative Health Registries, which will also serve as the primary source for data collection. Contact with potential participants will be made via the mandatory Danish electronic letter system. No scheduled in-person visits are required in the main study, and all study interventions will be mailed to participants.

A substudy involving up to 600 participants will assess the effects of coenzyme Q10 and selenium on functional capacity, treatment compliance, biochemical biomarkers, and cardiac function and structure. This group will attend two in-person visits for additional evaluations, including echocardiography, blood sampling, and a 6-minute walk test at baseline and at the 1-year follow-up.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Coenzyme Q10 intervention, active

100 mg capsules given twice daily, per oral use

Group Type: EXPERIMENTAL

Coenzyme Q10 100 Milligrams Oral Capsule

Intervention Type: DIETARY_SUPPLEMENT

100 mg capsules given twice daily, per oral use.

Coenzyme Q10 intervention, placebo

Placebo matching coenzyme Q10

Group Type: PLACEBO_COMPARATOR

Coenzyme Q10 100 Milligrams Oral Capsule

Intervention Type: DIETARY_SUPPLEMENT

100 mg capsules given twice daily, per oral use.

Selenium intervention, active

100 μg tables given twice daily, per oral use

Group Type: EXPERIMENTAL

Selenium 100 Micrograms Oral Tablets

Intervention Type: DIETARY_SUPPLEMENT

100 μg tablets given twice daily, per oral use.

Selenium intervention, placebo

100 μg tables given twice daily, per oral use

Group Type: PLACEBO_COMPARATOR

Selenium 100 Micrograms Oral Tablets

Intervention Type: DIETARY_SUPPLEMENT

100 μg tablets given twice daily, per oral use.

Interventions

Coenzyme Q10 100 Milligrams Oral Capsule

100 mg capsules given twice daily, per oral use.

Intervention Type: DIETARY_SUPPLEMENT

Selenium 100 Micrograms Oral Tablets

100 μg tablets given twice daily, per oral use.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharma Nord

INDUSTRY

Sponsor Role: collaborator

Tor Biering-Sørensen

OTHER

Sponsor Role: lead

Responsible Party

Tor Biering-Sørensen

Professor, MD, MSc, MPH, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tor Biering-Sørensen, MD, MPH, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Locations

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Kristoffer G Skaarup, MD

Role: CONTACT

kristoffer.grundtvig.skaarup@regionh.dk

+4542451250

Tor Biering-Sørensen, MD, MPH, MSc, PhD

Role: CONTACT

tor.biering-soerensen@regionh.dk

+4528933590

Facility Contacts

Kristoffer G Skaarup, MD

Role: primary

kristoffer.grundtvig.skaarup@regionh.dk

+4542451250

Sine H Christensen, MSc

Role: backup

sine.hoejlund.christensen@regionh.dk

Other Identifiers

DANUTRIO-HF

Identifier Type: -

Identifier Source: org_study_id