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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57659

Enrollment

275

Registered

2024-10-10

Start date

2026-05-12

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure reduced ejection fraction (HFrEF) heart failure

Interventions

Patients will be 1:1 randomized to Selenium/CoQ10 (2 x 100 µg Selenium tablets&nbsp

[SelenoPrecise 100 µg, Pharma Nord, Denmark] and 2 x 100 mg coQ10 capsules&nbsp

[Bio-Quinon 100 mg B.I.D, Pharma Nord, Denmark], as one tablet/capsule morning&nbsp

and evening) or matching placebo in a double-blinded fashion.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. Outpatients with chronic HF, NYHA II - ambulatory IV 3. Serum NT-proBNP concentrations >600pg/mL if in sinus rhythm; >1000pg/mL if in AF

Exclusion criteria

Exclusion criteria: 1. History of myocardial infarction, myocarditis, percutaneous intervention,  cardiac surgery or stroke <30 days 2. The presence of a mechanical assist device  3. Scheduled for mechanical assist device or heart transplant 4. Limited life expectancy (<1 year) 5. Amyloid, hypertrophic obstructive or constrictive cardiomyopathy  6. End stage kidney disease for which chronic intermittent peritoneal or  haemodialysis

Design outcomes

Primary

Measure	Time frame
To study whether combined selenium/CoQ10 supplementation, on top of standard treatment (guideline-recommended therapy), reduces the composite primary endpoint of repeated HF hospitalizations, urgent HF visits and cardiovascular mortality, compared to placebo, in chronic HF	—

Secondary

Measure	Time frame
1. To assess whether selenium/CoQ10 reduces all-cause mortality 2. To assess whether selenium/CoQ10 reduces cardiovascular mortality 3. To assess whether selenium/CoQ10 reduces (repeated) HF hospitalizations 4. To assess whether selenium/CoQ10 reduces (repeated) urgent HF visits. EXPLORATORY OBJECTIVES 1. To assess whether selenium/CoQ10 reduces all-cause hospitalizations 2. To assess whether selenium/CoQ10 reduces unscheduled cardiovascular hospital visits 3. To assess whether selenium/CoQ10 reduces days alive out of hospital of patients 4. To assess side effects (including SUSARs) associated with study supplement 5. To assess the use of the nationwide quality registry infrastructure for heart failure care in The Netherlands	—

Measure

Time frame

1. To assess whether selenium/CoQ10 reduces all-cause mortality 2. To assess whether selenium/CoQ10 reduces cardiovascular mortality 3. To assess whether selenium/CoQ10 reduces (repeated) HF hospitalizations 4. To assess whether selenium/CoQ10 reduces (repeated) urgent HF visits. EXPLORATORY OBJECTIVES 1. To assess whether selenium/CoQ10 reduces all-cause hospitalizations 2. To assess whether selenium/CoQ10 reduces unscheduled cardiovascular hospital visits 3. To assess whether selenium/CoQ10 reduces days alive out of hospital of patients 4. To assess side effects (including SUSARs) associated with study supplement 5. To assess the use of the nationwide quality registry infrastructure for heart failure care in The Netherlands

—

Countries

Netherlands

Contacts

Public ContactE. Soeteman

Netherlands Heart Institute

info@heart-institute.nl030 233 3600

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026