A Registry-Based Randomised Controlled Trial With Heart 4 Data - SELEnium and CoQ10 NuTrition for Heart Failure: H4D-SELEQT-HF
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,100
- Locations
- 13
- Primary Endpoint
- Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Intervention: Matching Placebo (B) (Drug)
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)
Intervention: Selenium/CoQ10 (Dietary Supplement)
Outcomes
Primary Outcomes
Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death
Time Frame: ongoing, up to ~30 months
Total (first and subsequent) HF hospitalizations, urgent visits for HF visits and cardiovascular deaths with selenium/coQ10 compared to placebo.
Secondary Outcomes
- Total number of events of (repeated) HF hospitalization and (repeated) urgent HF visits(ongoing, up to ~30 months)
- Time to death from any cause(ongoing, up to ~30 months)
- Time to cardiovascular death(ongoing, up to ~30 months)