NCT07234422

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for phase_3 heart-failure

Timeline
56mo left

Started May 2026

Longer than P75 for phase_3 heart-failure

Geographic Reach
1 country

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

November 14, 2025

Last Update Submit

April 7, 2026

Conditions

Keywords

heart failureseleniumcoQ10registry based randomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    ongoing, up to ~30 months

Secondary Outcomes (3)

  • Total number of events of (repeated) HF hospitalization and (repeated) urgent HF visits

    ongoing, up to ~30 months

  • Time to death from any cause

    ongoing, up to ~30 months

  • Time to cardiovascular death

    ongoing, up to ~30 months

Other Outcomes (4)

  • Total number of (repeated) all cause hospitalizations

    ongoing, up to ~30 months

  • Total number of (repeated) unscheduled cardiovascular hospital visits

    ongoing, up to ~30 months

  • Total days alive out of hospital

    ongoing, up to ~30 months

  • +1 more other outcomes

Study Arms (2)

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)

Dietary Supplement: Selenium/CoQ10

Placebo

PLACEBO COMPARATOR
Drug: Matching Placebo (B)

Interventions

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)

Selenium/CoQ10

Matching Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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\*

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Location

AUMC

Amsterdam, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Catharina ziekenhuis Eindhoven

Eindhoven, Netherlands

Location

TREANT

Emmen, Netherlands

Location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

St Antonius ziekenhuis

Nieuwegein, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 22626835BACKGROUND
  • 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.

    PMID: 25282031BACKGROUND
  • 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.

    PMID: 31808274BACKGROUND
  • 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.

    PMID: 3856239BACKGROUND
  • 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.

    PMID: 26829748BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

Seleniumcoenzyme Q10

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Peter van der Meer, prof dr

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR
  • Jeroen Schaap, MD,PhD

    Amphia Hospital Breda

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SELEQT-HF Study Team

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations