Efficacy of Early Rhythm Control in AF With TR Patients
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: Anti-arrhythmic drugs for rhythm control, DC cardioversion, catheter ablation for rhythm control, Usual care.
- Кому может быть актуально
- Состояния в реестре: Atrial Fibrillation (AF), Tricuspid Regurgitation (TR). Базовые параметры: Без ограничений · 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
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Atrial fibrillation is frequently accompanied by tricuspid regurgitation and may contribute to right atrial and tricuspid annular remodeling, leading to progression of tricuspid regurgitation and adverse clinical outcomes. However, whether early rhythm control improves prognosis in patients with atrial fibrillation and tricuspid regurgitation remains unclear. This study will compare early rhythm control with usual care in these patients, using a composite outcome of cardiac death, heart failure admission, stroke, and tricuspid valve surgery.
Подробное описание
Atrial fibrillation and tricuspid regurgitation frequently coexist in clinical practice. Atrial fibrillation may promote right atrial enlargement and tricuspid annular dilatation, which can aggravate functional tricuspid regurgitation over time. Conversely, significant tricuspid regurgitation may further increase right-sided volume overload, worsen atrial remodeling, and contribute to the persistence or progression of atrial fibrillation. This bidirectional relationship may lead to heart failure, thromboembolic events, and an increased need for tricuspid valve intervention.
Although early rhythm control has been shown to improve cardiovascular outcomes in selected patients with atrial fibrillation, its clinical benefit in patients with concomitant tricuspid regurgitation has not been well established. In particular, it remains uncertain whether maintaining sinus rhythm at an early stage can slow the progression of right-sided cardiac remodeling, reduce heart failure events, and improve long-term prognosis in this population.
This study is designed to evaluate the prognostic impact of early rhythm control compared with usual care in patients with atrial fibrillation and tricuspid regurgitation. The primary endpoint will be a composite of cardiac death, heart failure admission, stroke, and tricuspid valve surgery. By comparing these clinically meaningful outcomes between the two treatment strategies, this study aims to clarify whether early rhythm control should be considered as an active therapeutic approach in patients with atrial fibrillation complicated by tricuspid regurgitation.
The study will use retrospectively collected data from patients diagnosed with atrial fibrillation and tricuspid regurgitation between January 1, 2013 and December 31, 2023. Clinical outcomes will be assessed during this observation period.
Вмешательства
- Препарат Anti-arrhythmic drugs for rhythm control
flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone - Процедура DC cardioversion, catheter ablation for rhythm control
Direct-current cardioversion may be performed to acutely restore sinus rhythm, particularly in patients with persistent atrial fibrillation or symptomatic rhythm deterioration. Catheter ablation may be considered as a more definitive rhythm-control strategy to reduce atrial fibrillation burden and maintain sinus rhythm over the long term. - Другое Usual care
General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary)
Первичные конечные точки
- A composite of cardiac death, hospitalization for heart failure, stroke, and tricuspid valve surgery [Срок оценки: From January 1, 2013 to December 31, 2023]
Вторичные конечные точки (6)
- All cause death [Срок оценки: From January 1, 2013 to December 31, 2023]
- Cardiac death [Срок оценки: From January 1, 2013 to December 31, 2023]
- Hospitalization for heart failure [Срок оценки: From January 1, 2013 to December 31, 2023]
- Stroke [Срок оценки: From January 1, 2013 to December 31, 2023]
- Tricuspid valve surgery [Срок оценки: From January 1, 2013 to December 31, 2023]
- Pacemaker implantation [Срок оценки: From January 1, 2013 to December 31, 2023]
Критерии участия
Критерии включения
- Patients with concomitant atrial fibrillation and tricuspid regurgitation.
Критерии исключения
- Patients with a history of valvular surgery
- Patients with congenital heart disease
- Patients with primary pulmonary hypertension
- Patients with CIED implantation prior to the diagnosis of tricuspid regurgitation
- Patients diagnosed with TR only after the initiation of rhythm control therapy for AF
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
South Korea · 1 центр
- Samsung Medical Center — Seoul
Идентификаторы
NCT: NCT07607093 · SMC 2025-05-075-1