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

Tor Biering-Sørensen

Status and phase: Not yet enrolling; Phase 3

Conditions: Heart Failure

Treatments: Dietary Supplement: Coenzyme Q10 100 Milligrams Oral Capsule; Dietary Supplement: Selenium 100 Micrograms Oral Tablets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06694727

DANUTRIO-HF

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 4,044 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

4,044 participants in 4 patient groups, including a placebo group

Coenzyme Q10 intervention, active

Experimental group

Description:

100 mg capsules given twice daily, per oral use

Treatment:

Dietary Supplement: Coenzyme Q10 100 Milligrams Oral Capsule

Coenzyme Q10 intervention, placebo

Placebo Comparator group

Description:

Placebo matching coenzyme Q10

Treatment:

Dietary Supplement: Coenzyme Q10 100 Milligrams Oral Capsule

Selenium intervention, active

Experimental group

Description:

100 μg tables given twice daily, per oral use

Treatment:

Dietary Supplement: Selenium 100 Micrograms Oral Tablets

Selenium intervention, placebo

Placebo Comparator group

Description:

100 μg tables given twice daily, per oral use

Treatment:

Dietary Supplement: Selenium 100 Micrograms Oral Tablets