Status:
RECRUITING
A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure
Lead Sponsor:
Tor Biering-Sørensen
Collaborating Sponsors:
Pharma Nord
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 i...
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 nutritiona...
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.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
4044 Patients enrolled
Trial Details
Trial ID
NCT06694727
Start Date
September 30 2025
End Date
June 1 2029
Last Update
October 3 2025
Active Locations (1)
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1
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Denmark, 2900