A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTor Biering-Sørensen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Factorial
Treatments tested in this trial
Coenzyme Q10 100 Milligrams Oral Capsule
Dietary supplement100 mg capsules given twice daily, per oral use.
Selenium 100 Micrograms Oral Tablets
Dietary supplement100 μg tablets given twice daily, per oral use.
Treatment groups
4,044 Participants
are divided into 4 treatment groupsGroup A: Coenzyme Q10 intervention, activeExperimental treatment 1 intervention
Group B: Coenzyme Q10 intervention, placeboPlacebo comparator 1 intervention
Group C: Selenium intervention, activeExperimental treatment 1 intervention
Group D: Selenium intervention, placeboPlacebo comparator 1 intervention
Trial outcomes
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tor Biering-Sørensen
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution
Pharma Nord
Collaborator
Source ClinicalTrials.gov