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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2030-12-31

Brief Summary

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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

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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

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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)

Group Type EXPERIMENTAL

Selenium/CoQ10

Intervention Type DIETARY_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)

Placebo

Group Type PLACEBO_COMPARATOR

Matching Placebo (B)

Intervention Type DRUG

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)

Intervention Type DIETARY_SUPPLEMENT

Matching Placebo (B)

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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\*

Exclusion Criteria

* 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
* Unable to sign informed consent
* (Unwilling to stop) use of over the counter supplements coQ10/selenium
* Peanut and/or soy allergy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Hartstichting

UNKNOWN

Sponsor Role collaborator

Pharma Nord

INDUSTRY

Sponsor Role collaborator

WCN (Werkgroep Cardiologische centra Nederland)

UNKNOWN

Sponsor Role collaborator

Netherlands Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

AUMC

Amsterdam, , Netherlands

Site Status

Amphia Ziekenhuis

Breda, , Netherlands

Site Status

Catharina ziekenhuis Eindhoven

Eindhoven, , Netherlands

Site Status

TREANT

Emmen, , Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

St Antonius ziekenhuis

Nieuwegein, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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SELEQT-HF Study Team

Role: CONTACT

+31 (0)503616161

Facility Contacts

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Marielle C van de Veerdonk, MD, PhD

Role: primary

0031205669111

Jeroen Schaap, MD, PhD

Role: primary

0031765955000

René Tio, MD, PhD

Role: primary

0031402399111

Solmaz Assa, MD, PhD

Role: primary

0031881292929

Kevin Damman, MD, PhD

Role: primary

0031503616161

Peter van der Meer, Prof Dr

Role: backup

0031503616161

Geert PJ van Hout, MD, PhD

Role: primary

0031883203000

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.

Reference Type BACKGROUND
PMID: 22626835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25282031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31808274 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3856239 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26829748 (View on PubMed)

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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