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.
NCT ID: NCT07234422
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
1100 participants
INTERVENTIONAL
2025-12-31
2030-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Selenium/CoQ10
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)
Selenium/CoQ10
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)
Placebo
Matching Placebo (B)
Matching Placebo
Interventions
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Selenium/CoQ10
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)
Matching Placebo
Eligibility Criteria
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Inclusion Criteria
* 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\*
Exclusion Criteria
* 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
* Unable to sign informed consent
* (Unwilling to stop) use of over the counter supplements coQ10/selenium
* Peanut and/or soy allergy
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Hartstichting
UNKNOWN
Pharma Nord
INDUSTRY
WCN (Werkgroep Cardiologische centra Nederland)
UNKNOWN
Netherlands Heart Institute
OTHER
Responsible Party
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Principal Investigators
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Peter van der Meer, prof dr
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Jeroen Schaap, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Amphia Hospital Breda
Locations
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Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
AUMC
Amsterdam, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Catharina ziekenhuis Eindhoven
Eindhoven, , Netherlands
TREANT
Emmen, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
St Antonius ziekenhuis
Nieuwegein, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Mortensen 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.
Bomer 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.
Folkers 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.
McKeag 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.
Related Links
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Other Identifiers
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METc 2025/02
Identifier Type: OTHER
Identifier Source: secondary_id
NL87982.042.24
Identifier Type: -
Identifier Source: org_study_id
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