MedTrace Logo

A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure

NCT06694727 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4044

Last updated 2025-10-03

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Coenzyme Q10 100 Milligrams Oral Capsule

100 mg capsules given twice daily, per oral use.

DIETARY_SUPPLEMENT

Selenium 100 Micrograms Oral Tablets

100 μg tablets given twice daily, per oral use.

Sponsors & Collaborators

  • Pharma Nord

    collaborator INDUSTRY

  • Tor Biering-Sørensen

    lead OTHER

Principal Investigators

  • Tor Biering-Sørensen, MD, MPH, MSc, PhD · Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-12-01
Completion
2029-06-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06694727 on ClinicalTrials.gov