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.

Netherlands Heart Institute

Status and phase: Not yet enrolling; Phase 3

Conditions: Heart Failure

Treatments: Drug: Matching Placebo (B); Dietary Supplement: Selenium/CoQ10

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07234422

NL87982.042.24

METc 2025/02 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,100 participants in 2 patient groups, including a placebo group

Selenium/CoQ10

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Selenium/CoQ10

Placebo

Placebo Comparator group

Treatment:

Drug: Matching Placebo (B)