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NCT Number: NCT06694727

A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Hellerup, 2900, Denmark

Location status: Recruiting

Location contact

Kristoffer G Skaarup, MD

CONTACT

[email protected]

+4542451250

Sine H Christensen, MSc

CONTACT

[email protected]

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

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coenzyme Q10 100 Milligrams Oral Capsule

Dietary Supplement

100 mg capsules given twice daily, per oral use.

Selenium 100 Micrograms Oral Tablets

Dietary Supplement

100 μg tablets given twice daily, per oral use.

Primary outcomes

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

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

Secondary outcomes

  1. Time to first occurrence of hospitalization for heart failure

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

  2. Time to cardiovascular death

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

Other outcomes

  1. Total number of hospitalizations for heart failure

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

  2. Total number of hospitalizations for heart failure and cardiovascular death

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

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

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

  4. Total number of hospitalizations for heart failure and all-cause death

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

  5. Time to all-cause mortality

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

  6. Time to first occurrence of major adverse cardiovascular events

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

  7. Total number of major adverse cardiovascular events

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

  8. Time to first occurrence of hospitalization for any cardiovascular disease

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

  9. Total number of hospitalizations for any cardiovascular disease

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

  10. Time to first occurrence of hospitalization for any cardiorespiratory disease

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

  11. Total number of hospitalizations for any cardiorespiratory disease

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

  12. Time to first hospitalization for atrial fibrillation

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

  13. Total number of hospitalizations for atrial fibrillation

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

  14. Time to first occurrence of hospitalization for cardiac arrest

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

  15. Time to first hospitalization for any cause

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

  16. Total number of hospitalizations for any cause

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

  17. Change in Kansas City Cardiomyopathy Questionnaire Score

    Time frame: Aproximately within 1 year after randomization

  18. Change in left ventricular ejection fraction assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  19. Change in left ventricular global longitudinal strain assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  20. Change in E/e'-ratio assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  21. Change in left ventricular mass assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  22. Change in interventricular septal wall thickness assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  23. Change in left ventricular posterior thickness assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  24. Change in left atrial volume assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  25. Change in left atrial resevoir strain assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  26. Change in left atrial contraction strain assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  27. Change in left atrial conduit strain assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  28. Change in tricuspid annular plane systolic excursion assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  29. Change in right ventricular free wall longitudinal strain assessed with echocardiography

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  30. Change in pro-BNP

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  31. Change in high sensitivity troponin-I

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  32. Change in hs-CRP

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  33. Concentration of coenzyme Q10 at followup

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  34. Concentration of selenoprotein P and selenium at followup

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

  35. Change in 6 minute walking distance

    Time frame: Aproximately within 1 year after randomization

    In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after

Study contacts

Contact information is provided by the study sponsor or research team.

Kristoffer G Skaarup, MD

CONTACT

[email protected]

+4542451250

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

CONTACT

[email protected]

+4528933590

Sponsors and collaborators

Lead sponsor

Tor Biering-Sørensen

Other

Collaborators

  • Pharma Nord

Registry information

Official study title

A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure (DANUTRIO-HF: Q10, DANUTRIO-HF: Selenium)

Acronym: DANUTRIO-HF

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Nov 19, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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