Heart FailurePhase 3DANUTRIO-HFNCT06694727
A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure
A Phase 3 study testing Coenzyme Q10 100 Milligrams Oral Capsule and Selenium 100 Micrograms Oral Tablets in people with Heart Failure, run by Tor Biering-Sørensen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Coenzyme Q10 100 Milligrams Oral Capsule and Selenium 100 Micrograms Oral Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,044 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Sep 2025to 1 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, 2900
Kristoffer G Skaarup, MD, +4542451250, kristoffer.grundtvig.skaarup@regionh.dk
Sine H Christensen, MSc, sine.hoejlund.christensen@regionh.dk
About this study
Official title: A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure (DANUTRIO-HF: Q10, DANUTRIO-HF: Selenium)
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.
Read the 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 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.
- Conditions
- Heart Failure
- Being tested
- Coenzyme Q10 100 Milligrams Oral Capsule, Selenium 100 Micrograms Oral Tablets
- Keywords
- Heart failure, Coenzyme Q10, Selenium, Randomized Controlled Trial, Registry, Echocardiography, Pragmatic, Factorial, 2x2, Cardiovascular, Nutritional supplements
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10 100 Milligrams Oral CapsuleDietary supplement
100 mg capsules given twice daily, per oral use.
Selenium 100 Micrograms Oral TabletsDietary supplement
100 μg tablets given twice daily, per oral use.
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 intervention, active | Experimental | 100 mg capsules given twice daily, per oral use Receives: Dietary Supplement: Coenzyme Q10 100 Milligrams Oral Capsule |
| Coenzyme Q10 intervention, placebo | Placebo comparator | Placebo matching coenzyme Q10 Receives: Dietary Supplement: Coenzyme Q10 100 Milligrams Oral Capsule |
| Selenium intervention, active | Experimental | 100 μg tables given twice daily, per oral use Receives: Dietary Supplement: Selenium 100 Micrograms Oral Tablets |
| Selenium intervention, placebo | Placebo comparator | 100 μg tables given twice daily, per oral use Receives: Dietary Supplement: Selenium 100 Micrograms Oral Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first occurrence of hospitalization for heart failure or cardiovascular death
Measured: From date of randomization until end of study (Up to approximately 33 months)
Secondary outcomes (2)
Time to first occurrence of hospitalization for heart failure
Measured: From date of randomization until end of study (Up to approximately 33 months)
Time to cardiovascular death
Measured: From date of randomization until end of study (Up to approximately 33 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start30 Sep 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants will be randomized in a 1:1 fashion to receive either the experimental intervention or placebo for each of the two nutritional supplements.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,044 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Collaborators
- Pharma Nord
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
- Investigators
- Tor Biering-Sørensen, MD, MPH, MSc, PhD, Principal investigator, Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694727
- Sponsor's protocol ID
- DANUTRIO-HF
- Acronym
- DANUTRIO-HF
- Status last verified
- Sep 2025
- First submitted
- 28 Oct 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Most data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure (DANUTRIO-HF: Q10, DANUTRIO-HF: Selenium)
- ClinicalTrials.gov ID
- NCT06694727
- Acronym / sponsor ID
- DANUTRIO-HF / DANUTRIO-HF
- Conditions
- Heart Failure
- Keywords
- Heart failure, Coenzyme Q10, Selenium, Randomized Controlled Trial, Registry, Echocardiography, Pragmatic, Factorial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,044 participants (estimated)
- Lead sponsor
- Tor Biering-SørensenUniversity, hospital or other
- Collaborators
- Pharma Nord
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomized in a 1:1 fashion to receive either the experimental intervention or placebo for each of the two nutritional supplements.
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 intervention, active | Experimental | Dietary Supplement: Coenzyme Q10 100 Milligrams Oral Capsule100 mg capsules given twice daily, per oral use |
| Coenzyme Q10 intervention, placebo | Placebo comparator | Dietary Supplement: Coenzyme Q10 100 Milligrams Oral CapsulePlacebo matching coenzyme Q10 |
| Selenium intervention, active | Experimental | Dietary Supplement: Selenium 100 Micrograms Oral Tablets100 μg tables given twice daily, per oral use |
| Selenium intervention, placebo | Placebo comparator | Dietary Supplement: Selenium 100 Micrograms Oral Tablets100 μg tables given twice daily, per oral use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10 100 Milligrams Oral Capsule100 mg capsules given twice daily, per oral use. | Dietary supplement | Coenzyme Q10 intervention, active, Coenzyme Q10 intervention, placebo |
| Selenium 100 Micrograms Oral Tablets100 μg tablets given twice daily, per oral use. | Dietary supplement | Selenium intervention, active, Selenium intervention, placebo |
Primary outcome
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)
2 secondary outcomes
Time to first occurrence of hospitalization for heart failure
Time frame: From date of randomization until end of study (Up to approximately 33 months)
Time to cardiovascular death
Time frame: From date of randomization until end of study (Up to approximately 33 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes. Most data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tor Biering-Sørensen, MD, MPH, MSc, PhD principal investigator
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coenzyme Q10 100 Milligrams Oral Capsule and Selenium 100 Micrograms Oral Tablets in people with Heart Failure, run by Tor Biering-Sørensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristoffer G Skaarup, MD (+4542451250, kristoffer.grundtvig.skaarup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.