NCT07234422

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Netherlands Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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)
DRUG	Matching Placebo (B)	Matching Placebo

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-11-18
• Last updated: 2026-04-08

Locations

7 sites across 1 country: Netherlands