A Registry-Based Randomised Controlled Trial With Heart 4 Data - SELEnium and CoQ10 NuTrition for Heart Failure: H4D-SELEQT-HF
Heart Failure Study Evaluates Selenium and CoQ10
Plain English Summary
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. is a Phase 3 clinical trial sponsored by Netherlands Heart Institute studying Heart Failure. Tests if selenium and CoQ10 supplements improve heart health and reduce heart failure events in adults. For patients with chronic heart failure, aged 18 and over, with high NT-proBNP levels. Participation involves taking supplements or placebo in addition to usual heart failure treatment and attending routine clinical visits. Alternative treatments include standard heart failure medications and lifestyle changes. The trial aims to enroll 1100 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Ages 18 and over, with chronic heart failure, NYHA II-IV, and high NT-proBNP levels. Excluded if had a heart attack, surgery, or stroke in the last 30 days, or have certain heart conditions or allergies. This trial is studying Heart Failure, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the reduction in heart failure hospitalizations and deaths, which means fewer hospital visits and better survival for patients. The specific primary outcome measures are: Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death (ongoing, up to ~30 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to fill a gap in treatment options for heart failure patients, potentially offering a safe and effective supplement. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Heart Failure, where improved treatment options are needed.
Investor Insight
The large market size and competitive landscape suggest a high approval probability for this innovative supplement. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1100 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you meet the age and heart condition criteria. Participation involves taking supplements or placebo daily and attending routine clinical visits. The trial is being conducted at 7 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: TRIPLE
- Enrollment: 1,100 participants
Interventions
- 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
Primary Outcomes
- Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death (ongoing, up to ~30 months)
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)
Full 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
Trial Locations
- Noordwest Ziekenhuisgroep, Alkmaar, Netherlands
- AUMC, Amsterdam, Netherlands
- Amphia Ziekenhuis, Breda, Netherlands
- Catharina ziekenhuis Eindhoven, Eindhoven, Netherlands
- TREANT, Emmen, Netherlands
- University Medical Center Groningen, Groningen, Netherlands
- St Antonius ziekenhuis, Nieuwegein, Netherlands
Frequently Asked Questions
What is clinical trial NCT07234422?
NCT07234422 is a Phase 3 INTERVENTIONAL study titled "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.." It is currently not yet recruiting and is sponsored by Netherlands Heart Institute. The trial targets enrollment of 1100 participants.
What conditions does NCT07234422 study?
This trial investigates treatments for Heart Failure. The primary condition under study is Heart Failure.
What treatments are being tested in NCT07234422?
The interventions being studied include: Selenium/CoQ10 (DIETARY_SUPPLEMENT), Matching Placebo (B) (DRUG). 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)
What does Phase 3 mean for NCT07234422?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07234422?
This trial is currently "Not Yet Recruiting." It started on 2026-05-01. The estimated completion date is 2030-12.
Who is sponsoring NCT07234422?
NCT07234422 is sponsored by Netherlands Heart Institute. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07234422?
The trial aims to enroll 1100 participants. The trial has not yet started recruiting.
How is NCT07234422 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs triple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07234422?
The primary outcome measures are: Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death (ongoing, up to ~30 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07234422 being conducted?
This trial is being conducted at 7 sites, including Alkmaar; Amsterdam; Breda; Eindhoven and 3 more sites (Netherlands).
Where can I find official information about NCT07234422?
The official record for NCT07234422 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07234422. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07234422 testing in simple terms?
Tests if selenium and CoQ10 supplements improve heart health and reduce heart failure events in adults. For patients with chronic heart failure, aged 18 and over, with high NT-proBNP levels.
Why is this trial significant?
This trial aims to fill a gap in treatment options for heart failure patients, potentially offering a safe and effective supplement. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07234422?
Potential side effects are minimal, as selenium and CoQ10 are natural nutrients with no known health risks. Monitor for any unusual symptoms and report them to your healthcare provider. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07234422?
Ask your doctor if you meet the age and heart condition criteria. Participation involves taking supplements or placebo daily and attending routine clinical visits. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07234422 signal from an investment perspective?
The large market size and competitive landscape suggest a high approval probability for this innovative supplement. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves taking supplements or placebo in addition to usual heart failure treatment and attending routine clinical visits. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.