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| ID | Type | Description | Link |
|---|---|---|---|
| METc 2025/02 | Other Identifier | METc UMC Groningen |
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| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Hartstichting | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selenium/CoQ10 | Experimental | 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) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selenium/CoQ10 | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death | Total (first and subsequent) HF hospitalizations, urgent visits for HF visits and cardiovascular deaths with selenium/coQ10 compared to placebo. | ongoing, up to ~30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of events of (repeated) HF hospitalization and (repeated) urgent HF visits | Total number of (repeated) HF hospitalization and (repeated) urgent HF visits | ongoing, up to ~30 months |
| Time to death from any cause |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of (repeated) all cause hospitalizations | Total number of (repeated) all cause hospitalizations with selenium/coQ10 compared to placebo | ongoing, up to ~30 months |
| Total number of (repeated) unscheduled cardiovascular hospital visits |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SELEQT-HF Study Team | Contact | +31 (0)503616161 | seleqt-hf@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Peter van der Meer, prof dr | University Medical Center Groningen | Principal Investigator |
| Jeroen Schaap, MD,PhD | Amphia Hospital Breda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noordwest Ziekenhuisgroep | Not yet recruiting | Alkmaar | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22626835 | Background | Alehagen U, Johansson P, Bjornstedt M, Rosen A, Dahlstrom U. Cardiovascular mortality and N-terminal-proBNP reduced after combined selenium and coenzyme Q10 supplementation: a 5-year prospective randomized double-blind placebo-controlled trial among elderly Swedish citizens. Int J Cardiol. 2013 Sep 1;167(5):1860-6. doi: 10.1016/j.ijcard.2012.04.156. Epub 2012 May 23. | |
| 25282031 |
| Label | URL |
|---|---|
| ZonMW project page SELEQT-HF | View source |
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| Pharma Nord |
| INDUSTRY |
| WCN (Werkgroep Cardiologische centra Nederland) | UNKNOWN |
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| Matching Placebo (B) | Drug | Matching Placebo |
|
time to death from any cause with selenium/coQ10 compared to placebo
| ongoing, up to ~30 months |
| Time to cardiovascular death | Time to cardiovascular death with selenium/coQ10 compared to placebo | ongoing, up to ~30 months |
Total number of (repeated) unscheduled cardiovascular hospital visits with selenium/coQ10 compared to placebo
| ongoing, up to ~30 months |
| Total days alive out of hospital | Total days alive out of hospital with selenium/coQ10 compared to placebo | ongoing, up to ~30 months |
| Side effects associated with study supplement | Side effects associated with study supplement | ongoing, up to 30 months |
| AUMC | Not yet recruiting | Amsterdam | Netherlands |
|
| Amphia Ziekenhuis | Recruiting | Breda | Netherlands |
|
| Catharina ziekenhuis Eindhoven | Not yet recruiting | Eindhoven | Netherlands |
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| TREANT | Not yet recruiting | Emmen | Netherlands |
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| University Medical Center Groningen | Recruiting | Groningen | 9713GZ | Netherlands |
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| St Antonius ziekenhuis | Not yet recruiting | Nieuwegein | Netherlands |
|
| Background |
| Mortensen SA, Rosenfeldt F, Kumar A, Dolliner P, Filipiak KJ, Pella D, Alehagen U, Steurer G, Littarru GP; Q-SYMBIO Study Investigators. The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial. JACC Heart Fail. 2014 Dec;2(6):641-9. doi: 10.1016/j.jchf.2014.06.008. Epub 2014 Oct 1. |
| 31808274 | Background | Bomer N, Grote Beverborg N, Hoes MF, Streng KW, Vermeer M, Dokter MM, IJmker J, Anker SD, Cleland JGF, Hillege HL, Lang CC, Ng LL, Samani NJ, Tromp J, van Veldhuisen DJ, Touw DJ, Voors AA, van der Meer P. Selenium and outcome in heart failure. Eur J Heart Fail. 2020 Aug;22(8):1415-1423. doi: 10.1002/ejhf.1644. Epub 2019 Dec 6. |
| 3856239 | Background | Folkers K, Vadhanavikit S, Mortensen SA. Biochemical rationale and myocardial tissue data on the effective therapy of cardiomyopathy with coenzyme Q10. Proc Natl Acad Sci U S A. 1985 Feb;82(3):901-4. doi: 10.1073/pnas.82.3.901. |
| 26829748 | Background | McKeag NA, McKinley MC, Harbinson MT, McGinty A, Neville CE, Woodside JV, McKeown PP. Dietary Micronutrient Intake and Micronutrient Status in Patients With Chronic Stable Heart Failure: An Observational Study. J Cardiovasc Nurs. 2017 Mar/Apr;32(2):148-155. doi: 10.1097/JCN.0000000000000322. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012643 | Selenium |
| C024989 | coenzyme Q10 |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
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