Heart FailurePhase 3SELEQT-HFNCT07234422
The SELEQT-HF (SELEnium and CoQ10 NuTrition for Heart Failure) Study Will Evaluate the Effect of Adding Selenium/and coQ10 on Top of Standard HF Therapy in Patients With HF and Will do so Using a Pragmatic, Registry Based Randomized Controlled Trial in the Netherlands.
A Phase 3 study testing Selenium/CoQ10 in people with Heart Failure, run by Netherlands Heart Institute at 7 sites in Netherlands.
Trial summary
The goal of this clinical trial is to learn whether taking selenium and coenzyme Q10 (CoQ10) can reduce HF related events and deaths related to cardiovascular disease. Researchers will compare selenium-CoQ10 supplements with a placebo to see if the supplements improve heart health and patient outcomes. 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?
- Selenium/CoQ10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 7 sitesNetherlands
- Study dates
- 4 May 2026to Dec 2030
- 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
- Age >18 years
- Outpatients with chronic HF, NYHA II - ambulatory IV
- Serum NT-proBNP concentrations >600 pg/mL (71 pmol/L) if in sinus rhythm; >1000pg/mL (118 pmol/L) if in Atrial fibrillation*
Who cannot join
- History of myocardial infarction, myocarditis, percutaneous intervention, cardiac surgery or stroke <30 days
- The presence of a mechanical assist device
- Scheduled for mechanical assist device or heart transplant
- Other non-cardiac conditions with limited life expectancy (<1 year)
- Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
- End stage kidney disease for which chronic intermittent peritoneal or haemodialysis
Show all 9Show fewer
- Unable to sign informed consent
- (Unwilling to stop) use of over the counter supplements coQ10/selenium
- Peanut and/or soy allergy
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Netherlands7 sites, 7 recruiting
- Not yet recruiting
Noordwest Ziekenhuisgroep
Alkmaar
Jan van Ramshorst, MD, PhD, 0031725484444, seleqt-hf@umcg.nl
- Not yet recruiting
AUMC
Amsterdam
Marielle C van de Veerdonk, MD, PhD, 0031205669111, seleqt-hf@umcg.nl
- Recruiting
Amphia Ziekenhuis
Breda
Jeroen Schaap, MD, PhD, 0031765955000, seleqt-hf@umcg.nl
- Not yet recruiting
Catharina ziekenhuis Eindhoven
Eindhoven
René Tio, MD, PhD, 0031402399111, seleqt-hf@umcg.nl
- Not yet recruiting
TREANT
Emmen
Solmaz Assa, MD, PhD, 0031881292929, seleqt-hf@umcg.nl
- Recruiting
University Medical Center Groningen
Groningen, 9713GZ
Kevin Damman, MD, PhD, 0031503616161, seleqt-hf@umcg.nl
Peter van der Meer, Prof Dr, 0031503616161, seleqt-hf@umcg.nl
- Not yet recruiting
St Antonius ziekenhuis
Nieuwegein
Geert PJ van Hout, MD, PhD, 0031883203000, seleqt-hf@umcg.nl
About this study
Official title: A Registry-Based Randomised Controlled Trial With Heart 4 Data - SELEnium and CoQ10 NuTrition for Heart Failure: H4D-SELEQT-HF
The goal of this clinical trial is to learn whether taking selenium and coenzyme Q10 (CoQ10) can reduce HF related events and deaths related to cardiovascular disease.
Researchers will compare selenium-CoQ10 supplements with a placebo to see if the supplements improve heart health and patient outcomes.
Read more
Participants will:
Receive either selenium-CoQ10 or placebo in addition to their usual heart failure treatment
Attend standard clinical visits according to routine clinical care.
The study will include 1,100 adults with chronic heart failure. Selenium and CoQ10 are natural nutrients with no known health risks. If effective, this supplement could provide a safe new way to improve outcomes for people with heart failure.
Read the detailed description
This randomized controlled trial will be a pragmatic registry based clinical trial (RBRCT), using existing infrastructure on quality reporting of cardiovascular disease management in the Netherlands. This registration platform (Netherlands Heart Registration (NHR) forms the basis of incorporating information of patients with HF in hospitals in the Netherlands. Using the data gathered through this registry, these data will serve as source documentation for the electronic case report form of the current RBRCT and requires only limited additional information. Through the same system, randomization, (Serious) adverse event reporting, endpoint reporting and investigational product allocation will be conducted. Investigational product (selenium/CoQ10 supplementation or placebo) will be distributed from central pharmacy to the home of the patient. Apart from telephone calls at 6 months after randomization and every 12 months thereafter, there will be no study visits and the data gathering will be conducted through routine clinical care and registrations that are already in place. SELEQT-HF is an event driven RBRCT, with an expected median follow up of 2 years.
- Conditions
- Heart Failure
- Being tested
- Selenium/CoQ10, Matching Placebo (B)
- Keywords
- heart failure, selenium, coQ10, registry based randomized clinical trial
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium/CoQ10Dietary supplement
Oral dosage of twice daily Selenium/CoQ10 (2 x 100 μg selenium tablets (SelenoPrecise 100 μg, Pharma Nord, Denmark) and 2 x 100 mg Q10 capsules (Bio-Quinon 100 mg B.I.D, Pharma Nord, Denmark)
Matching Placebo (B)Drug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Selenium/CoQ10 | Experimental | Oral dosage of twice daily Selenium/CoQ10 (2 x 100 μg selenium tablets (SelenoPrecise 100 μg, Pharma Nord, Denmark) and 2 x 100 mg Q10 capsules (Bio-Quinon 100 mg B.I.D, Pharma Nord, Denmark) Receives: Dietary Supplement: Selenium/CoQ10 |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching Placebo (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death
Total (first and subsequent) HF hospitalizations, urgent visits for HF visits and cardiovascular deaths with selenium/coQ10 compared to placebo.
Measured: ongoing, up to ~30 months
Secondary outcomes (3)
Total number of events of (repeated) HF hospitalization and (repeated) urgent HF visits
Total number of (repeated) HF hospitalization and (repeated) urgent HF visits
Measured: ongoing, up to ~30 months
Time to death from any cause
time to death from any cause with selenium/coQ10 compared to placebo
Measured: ongoing, up to ~30 months
Time to cardiovascular death
Time to cardiovascular death with selenium/coQ10 compared to placebo
Measured: ongoing, up to ~30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start4 May 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Netherlands Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, ZonMw: The Netherlands Organisation for Health Research and Development, Hartstichting, Pharma Nord, WCN (Werkgroep Cardiologische centra Nederland)
- Responsible party
- Sponsor
- Investigators
- Peter van der Meer, prof dr, Principal investigator, University Medical Center GroningenJeroen Schaap, MD,PhD, Principal investigator, Amphia Hospital Breda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234422
- Sponsor's protocol ID
- NL87982.042.24
- Other IDs
- METc 2025/02
- Acronym
- SELEQT-HF
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alehagen U, Johansson P, Bjornstedt M, Rosen A, Dahlstrom U. Cardiovascular mortality and N-terminal-proBNP reduced after combined selenium and coenzyme Q10 supplementation: a 5-year prospective randomized double-blind placebo-controlled trial among elderly Swedish citizens. Int J Cardiol. 2013 Sep 1;167(5):1860-6. doi: 10.1016/j.ijcard.2012.04.156. Epub 2012 May 23.
PubMed 22626835Mortensen SA, Rosenfeldt F, Kumar A, Dolliner P, Filipiak KJ, Pella D, Alehagen U, Steurer G, Littarru GP; Q-SYMBIO Study Investigators. The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial. JACC Heart Fail. 2014 Dec;2(6):641-9. doi: 10.1016/j.jchf.2014.06.008. Epub 2014 Oct 1.
PubMed 25282031Bomer N, Grote Beverborg N, Hoes MF, Streng KW, Vermeer M, Dokter MM, IJmker J, Anker SD, Cleland JGF, Hillege HL, Lang CC, Ng LL, Samani NJ, Tromp J, van Veldhuisen DJ, Touw DJ, Voors AA, van der Meer P. Selenium and outcome in heart failure. Eur J Heart Fail. 2020 Aug;22(8):1415-1423. doi: 10.1002/ejhf.1644. Epub 2019 Dec 6.
PubMed 31808274Folkers K, Vadhanavikit S, Mortensen SA. Biochemical rationale and myocardial tissue data on the effective therapy of cardiomyopathy with coenzyme Q10. Proc Natl Acad Sci U S A. 1985 Feb;82(3):901-4. doi: 10.1073/pnas.82.3.901.
PubMed 3856239McKeag NA, McKinley MC, Harbinson MT, McGinty A, Neville CE, Woodside JV, McKeown PP. Dietary Micronutrient Intake and Micronutrient Status in Patients With Chronic Stable Heart Failure: An Observational Study. J Cardiovasc Nurs. 2017 Mar/Apr;32(2):148-155. doi: 10.1097/JCN.0000000000000322.
PubMed 26829748
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry-Based Randomised Controlled Trial With Heart 4 Data - SELEnium and CoQ10 NuTrition for Heart Failure: H4D-SELEQT-HF
- ClinicalTrials.gov ID
- NCT07234422
- Acronym / sponsor ID
- SELEQT-HF / NL87982.042.24
- Conditions
- Heart Failure
- Keywords
- heart failure, selenium, coQ10, registry based randomized clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Netherlands Heart InstituteUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, ZonMw: The Netherlands Organisation for Health Research and Development, Hartstichting, Pharma Nord, WCN (Werkgroep Cardiologische centra Nederland)
- Study start
- 4 May 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Nov 2025 (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.
The goal of this clinical trial is to learn whether taking selenium and coenzyme Q10 (CoQ10) can reduce HF related events and deaths related to cardiovascular disease.
Researchers will compare selenium-CoQ10 supplements with a placebo to see if the supplements improve heart health and patient outcomes.
Participants will:
Receive either selenium-CoQ10 or placebo in addition to their usual heart failure treatment
Attend standard clinical visits according to routine clinical care.
The study will include 1,100 adults with chronic heart failure. Selenium and CoQ10 are natural nutrients with no known health risks. If effective, this supplement could provide a safe new way to improve outcomes for people with heart failure.
Detailed description
This randomized controlled trial will be a pragmatic registry based clinical trial (RBRCT), using existing infrastructure on quality reporting of cardiovascular disease management in the Netherlands. This registration platform (Netherlands Heart Registration (NHR) forms the basis of incorporating information of patients with HF in hospitals in the Netherlands. Using the data gathered through this registry, these data will serve as source documentation for the electronic case report form of the current RBRCT and requires only limited additional information. Through the same system, randomization, (Serious) adverse event reporting, endpoint reporting and investigational product allocation will be conducted. Investigational product (selenium/CoQ10 supplementation or placebo) will be distributed from central pharmacy to the home of the patient. Apart from telephone calls at 6 months after randomization and every 12 months thereafter, there will be no study visits and the data gathering will be conducted through routine clinical care and registrations that are already in place. SELEQT-HF is an event driven RBRCT, with an expected median follow up of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selenium/CoQ10 | Experimental | Dietary Supplement: Selenium/CoQ10Oral dosage of twice daily Selenium/CoQ10 (2 x 100 μg selenium tablets (SelenoPrecise 100 μg, Pharma Nord, Denmark) and 2 x 100 mg Q10 capsules (Bio-Quinon 100 mg B.I.D, Pharma Nord, Denmark) |
| Placebo | Placebo comparator | Drug: Matching Placebo (B) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Outpatients with chronic HF, NYHA II - ambulatory IV
- Serum NT-proBNP concentrations >600 pg/mL (71 pmol/L) if in sinus rhythm; >1000pg/mL (118 pmol/L) if in Atrial fibrillation*
Key exclusion criteria (9 listed)
- History of myocardial infarction, myocarditis, percutaneous intervention, cardiac surgery or stroke <30 days
- The presence of a mechanical assist device
- Scheduled for mechanical assist device or heart transplant
- Other non-cardiac conditions with limited life expectancy (<1 year)
- Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
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 |
|---|---|---|
| Selenium/CoQ10Oral dosage of twice daily Selenium/CoQ10 (2 x 100 μg selenium tablets (SelenoPrecise 100 μg, Pharma Nord, Denmark) and 2 x 100 mg Q10 capsules (Bio-Quinon 100 mg B.I.D, Pharma Nord, Denmark) | Dietary supplement | Selenium/CoQ10 |
| Matching Placebo (B)Matching Placebo | Drug | Placebo |
Primary outcome
Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death
Time frame: ongoing, up to ~30 months
Total (first and subsequent) HF hospitalizations, urgent visits for HF visits and cardiovascular deaths with selenium/coQ10 compared to placebo.
3 secondary outcomes
Total number of events of (repeated) HF hospitalization and (repeated) urgent HF visits
Time frame: ongoing, up to ~30 months
Time to death from any cause
Time frame: ongoing, up to ~30 months
Time to cardiovascular death
Time frame: ongoing, up to ~30 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 19 May 2026.
- Background: PubMed 22626835Alehagen U, Johansson P, Bjornstedt M, Rosen A, Dahlstrom U. Cardiovascular mortality and N-terminal-proBNP reduced after combined selenium and coenzyme Q10 supplementation: a 5-year prospective randomized double-blind placebo-controlled trial among elderly Swedish citizens. Int J Cardiol. 2013 Sep 1;167(5):1860-6. doi: 10.1016/j.ijcard.2012.04.156. Epub 2012 May 23.
- Background: PubMed 25282031Mortensen SA, Rosenfeldt F, Kumar A, Dolliner P, Filipiak KJ, Pella D, Alehagen U, Steurer G, Littarru GP; Q-SYMBIO Study Investigators. The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial. JACC Heart Fail. 2014 Dec;2(6):641-9. doi: 10.1016/j.jchf.2014.06.008. Epub 2014 Oct 1.
- Background: PubMed 31808274Bomer N, Grote Beverborg N, Hoes MF, Streng KW, Vermeer M, Dokter MM, IJmker J, Anker SD, Cleland JGF, Hillege HL, Lang CC, Ng LL, Samani NJ, Tromp J, van Veldhuisen DJ, Touw DJ, Voors AA, van der Meer P. Selenium and outcome in heart failure. Eur J Heart Fail. 2020 Aug;22(8):1415-1423. doi: 10.1002/ejhf.1644. Epub 2019 Dec 6.
- Background: PubMed 3856239Folkers K, Vadhanavikit S, Mortensen SA. Biochemical rationale and myocardial tissue data on the effective therapy of cardiomyopathy with coenzyme Q10. Proc Natl Acad Sci U S A. 1985 Feb;82(3):901-4. doi: 10.1073/pnas.82.3.901.
- Background: PubMed 26829748McKeag NA, McKinley MC, Harbinson MT, McGinty A, Neville CE, Woodside JV, McKeown PP. Dietary Micronutrient Intake and Micronutrient Status in Patients With Chronic Stable Heart Failure: An Observational Study. J Cardiovasc Nurs. 2017 Mar/Apr;32(2):148-155. doi: 10.1097/JCN.0000000000000322.
- ZonMW project page SELEQT-HFLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Peter van der Meer, prof dr principal investigator
University Medical Center Groningen
Jeroen Schaap, MD,PhD principal investigator
Amphia Hospital Breda
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selenium/CoQ10 in people with Heart Failure, run by Netherlands Heart Institute at 7 sites in Netherlands.
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 9 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. 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 SELEQT-HF Study Team (+31 (0)503616161, seleqt-hf@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death (time frame: ongoing, up to ~30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07234422, which also lists 5 linked publications.
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 19 May 2026.