A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure

NCT06694727 | Recruiting Phase 3

• 1 other identifier: DANUTRIO-HF
• Study Type: interventional
• Target: 4,044
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure; Coenzyme Q10; Selenium; Randomized Controlled Trial; Registry; Echocardiography; Pragmatic; Factorial; 2x2; Cardiovascular; Nutritional supplements

Outcome Measures

Primary Outcomes (1)

• Time to the first occurrence of hospitalization for heart failure or cardiovascular death

  From date of randomization until end of study (Up to approximately 33 months)

Secondary Outcomes (2)

• Time to first occurrence of hospitalization for heart failure

  From date of randomization until end of study (Up to approximately 33 months)

• Time to cardiovascular death

  From date of randomization until end of study (Up to approximately 33 months)

Other Outcomes (35)

• Total number of hospitalizations for heart failure

  From date of randomization until end of study (Up to approximately 33 months)

• Total number of hospitalizations for heart failure and cardiovascular death

  From date of randomization until end of study (Up to approximately 33 months)

• Time to the first occurrence of hospitalization for heart failure or all-cause death

  From date of randomization until end of study (Up to approximately 33 months)

Study Arms (4)

Coenzyme Q10 intervention, active

EXPERIMENTAL

100 mg capsules given twice daily, per oral use

Dietary Supplement: Coenzyme Q10 100 Milligrams Oral Capsule

Coenzyme Q10 intervention, placebo

PLACEBO COMPARATOR

Placebo matching coenzyme Q10

Dietary Supplement: Coenzyme Q10 100 Milligrams Oral Capsule

Selenium intervention, active

EXPERIMENTAL

100 μg tables given twice daily, per oral use

Dietary Supplement: Selenium 100 Micrograms Oral Tablets

Selenium intervention, placebo

PLACEBO COMPARATOR

100 μg tables given twice daily, per oral use

Dietary Supplement: Selenium 100 Micrograms Oral Tablets

Interventions

Coenzyme Q10 100 Milligrams Oral Capsule DIETARY_SUPPLEMENT

100 mg capsules given twice daily, per oral use.

Coenzyme Q10 intervention, active; Coenzyme Q10 intervention, placebo

Selenium 100 Micrograms Oral Tablets DIETARY_SUPPLEMENT

100 μg tablets given twice daily, per oral use.

Selenium intervention, active; Selenium intervention, placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tor Biering-Sørensen: lead
• Pharma Nord: collaborator

Study Sites (1)

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

Hellerup, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

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

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristoffer G Skaarup, MD

CONTACT

+4542451250; kristoffer.grundtvig.skaarup@regionh.dk

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

CONTACT

+4528933590; tor.biering-soerensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, MSc, MPH, PhD

Model Details: Participants will be randomized in a 1:1 fashion to receive either the experimental intervention or placebo for each of the two nutritional supplements.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 19, 2024
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (1)