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.

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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)
• Препарат Matching Placebo (B)
  Matching Placebo

Первичные конечные точки

• Composite of repeated HF hospitalization, repeated urgent HF visits and cardiovascular death [Срок оценки: ongoing, up to ~30 months]

Вторичные конечные точки (3)

• Total number of events of (repeated) HF hospitalization and (repeated) urgent HF visits [Срок оценки: ongoing, up to ~30 months]
• Time to death from any cause [Срок оценки: ongoing, up to ~30 months]
• Time to cardiovascular death [Срок оценки: ongoing, up to ~30 months]

Критерии участия

Критерии включения

• 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\*

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 7 центров

• Noordwest Ziekenhuisgroep — Alkmaar
• AUMC — Amsterdam
• Amphia Ziekenhuis — Breda
• Catharina ziekenhuis Eindhoven — Eindhoven
• TREANT — Emmen
• University Medical Center Groningen — Groningen
• St Antonius ziekenhuis — Nieuwegein

Публикации

• 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. PMID 22626835
• 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. PMID 25282031
• 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. PMID 31808274
• 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. PMID 3856239
• 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. PMID 26829748

Идентификаторы

NCT: NCT07234422 · NL87982.042.24 · METc 2025/02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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