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A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure

Study acronym: DANUTRIO-HF
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Apr 1, 2025 to Sep 30, 2025
    • Primary completion date: Aug 1, 2028 to Dec 1, 2028
    • Study completion date: Feb 1, 2029 to Jun 1, 2029
    • Site details revised
  2. Start date: Feb 1, 2025 to Apr 1, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06694727
Lead Sponsor Tor Biering-Sørensen
Collaborators: Pharma Nord
Conditions
(from sponsor)		 Heart Failure
Related terms Heart Failure
Enrollment 4,044 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov