A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Coenzyme Q10 100 Milligrams Oral Capsule, Selenium 100 Micrograms Oral Tablets.
- Кому может быть актуально
- Состояния в реестре: Heart Failure. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure (DANUTRIO-HF: Q10, DANUTRIO-HF: Selenium)
Обзор
Heart failure is a common and serious condition. Despite rapid advancements in heart failure treatment, the prognosis remains severe. Smaller studies have shown that two simple, safe, and relatively inexpensive nutritional supplements-coenzyme Q10 and selenium-may reduce the risk of complications associated with heart failure. The DANUTRIO-HF trial will investigate whether these supplements can make a difference for individuals with heart failure. The study will assign approximately 4,044 patients from across Denmark to either coenzyme Q10 (100 mg twice daily) or a corresponding placebo, as well as selenium (100 μg twice daily) or its corresponding placebo, and follow how many of them end up being hospitalized for heart failure or dying from heart problems over an estimated two to three-year period.
Подробное описание
This investigator-initiated, pragmatic, registry-based, double-blinded, placebo-controlled, 2x2 factorial, individually randomized trial aims to evaluate the efficacy of daily intake of the nutritional supplements coenzyme Q10 versus placebo, and selenium versus placebo, in preventing heart failure hospitalizations and cardiovascular death in heart failure patients. The trial plans to randomize approximately 4,044 participants in an event-driven design. Participants will be identified through the Danish Administrative Health Registries, which will also serve as the primary source for data collection. Contact with potential participants will be made via the mandatory Danish electronic letter system. No scheduled in-person visits are required in the main study, and all study interventions will be mailed to participants.
A substudy involving up to 600 participants will assess the effects of coenzyme Q10 and selenium on functional capacity, treatment compliance, biochemical biomarkers, and cardiac function and structure. This group will attend two in-person visits for additional evaluations, including echocardiography, blood sampling, and a 6-minute walk test at baseline and at the 1-year follow-up.
Вмешательства
- Пищевая добавка Coenzyme Q10 100 Milligrams Oral Capsule
100 mg capsules given twice daily, per oral use. - Пищевая добавка Selenium 100 Micrograms Oral Tablets
100 μg tablets given twice daily, per oral use.
Первичные конечные точки
- Time to the first occurrence of hospitalization for heart failure or cardiovascular death [Срок оценки: From date of randomization until end of study (Up to approximately 33 months)]
Вторичные конечные точки (2)
- Time to first occurrence of hospitalization for heart failure [Срок оценки: From date of randomization until end of study (Up to approximately 33 months)]
- Time to cardiovascular death [Срок оценки: From date of randomization until end of study (Up to approximately 33 months)]
Критерии участия
Критерии включения
- Individuals aged ≥ 18 years.
- Registered with a heart failure diagnosis (ICD-10: I50) as a primary discharge diagnosis in The Danish National Patient Registry and at least one claimed prescription of a renin-angiotensin-system inhibitor and a β-blocker within 120 days after HF diagnosis.
- Informed consent form has been signed and dated.
Критерии исключения
- Use of vitamin K-antagonist
- Registered with a cancer diagnosis (C00-C97 not C44) within the last 5 years excluding cutaneous squamous cell or basal cell carcinoma in The Danish National Patient Registry.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Факторный дизайн
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiol — Hellerup
Идентификаторы
NCT: NCT06694727 · DANUTRIO-HF