RecruitingPhase 3NCT07234422

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 Registry-Based Randomised Controlled Trial With Heart 4 Data - SELEnium and CoQ10 NuTrition for Heart Failure: H4D-SELEQT-HF


Sponsor

Netherlands Heart Institute

Enrollment

1,100 participants

Start Date

May 4, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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

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Interventions

DIETARY_SUPPLEMENTSelenium/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)

DRUGMatching Placebo (B)

Matching Placebo


Locations(7)

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

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NCT07234422


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