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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.

NCT07234422

RecruitingPhase 3

Sponsor: Netherlands Heart Institute

Conditions: Heart Failure

Interventions: Selenium/CoQ10, Matching Placebo (B)

Countries: Netherlands

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (7)

Alkmaar, Netherlands
Amsterdam, Netherlands
Breda, Netherlands
Eindhoven, Netherlands
Emmen, Netherlands
Groningen, Netherlands
Nieuwegein, Netherlands