Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)
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: Radiofrequency catheter ablation (RFCA), Medical Therapy.
- Кому может быть актуально
- Состояния в реестре: Atrial Fibrillation, HFpEF - Heart Failure With Preserved Ejection Fraction. Базовые параметры: 18 лет — 80 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
- Китай
- 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
Catheter Ablation in Atrial Fibrillation Patients With Heart Failure With Preserved Ejection Fraction: an International, Prospective, Multi-center, Randomized Controlled Study (STABLE-SR IV Trial)
Обзор
To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.
Подробное описание
Background: Atrial Fibrillation (AF) is a common cardiac rhythm disorder and radiofrequency catheter ablation (RFCA) has become the first-line therapy in the symptomatic AF patients. Heart failure is often the sister disease with AF. Recently, RFCA was found to be superior to antiarrhythmic drugs (AADs) in heart failure patients with AF and reduced ejection fraction (HFrEF), regarding all-cause mortality and hospitalization for worsening heart failure (HF). However, in heart failure patients with AF and preserved ejection fraction (HFpEF), it remains unknown whether RFCA is superior to AADs in an even larger population, despite several nonrandomized retrospective studies. Thus, this prospective, multi-center, randomized controlled trial aims to investigate whether RFCA could better improve the clinical outcome of AF patients with HFpEF than longterm AADs use.
Aim of this study: To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.
Design: The STABLE-SR-IV trial is an international, prospective, multi-center, randomized controlled trial. In this trial, physical examination, echocardiogram, NT-proBNP and other blood test would be assessed before enrollment. Those who conform to all the inclusion criteria and absent from any exclusion criteria would enter into a run-in period of 5 weeks (±7 days). Anticoagulation and anti-heart-failure therapy for HFpEF must be optimized according to the current guideline. After the run-in period, inclusion and exclusion criteria would be reassessed. Thereafter, all the subjects enrolled would be randomized into RFCA arm and Medical Therapy arm with a 1:1 manner, namely 218 subjects in each arm. Each arm will follow the protocol of RFCA and medical therapy, respectively. Follow-up duration of this study is up to 2\~3 years (12 month enrollment).
Вмешательства
- Процедура Radiofrequency catheter ablation (RFCA)
Radiofrequency ablation is adopted in the study, instead of cryo ablation, surgical ablation or pulsed field ablation. 3-dimensional model is constructed after transseptal puncture. Circumferential pulmonary vein isolation (CPVI) is performed with irrigated contact force catheter. Previously published STABLE-SR approach is recommended as the ablation strategy beyond CPVI. - Препарат Medical Therapy
AADs should be prescribed according to the current guidelines, such as amiodarone, dronedarone, or propafenone. In brief, rhythm control is preferred, including electric cardioversion. However, rate control should be considered if rhythm control is contraindicated, intolerated or unpreferred by patients.
Первичные конечные точки
- Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death (Time-to-first event analysis) [Срок оценки: From randomization until completion of the planned follow-up, up to 36 months]
Вторичные конечные точки (12)
- Time to hospitalization or urgent visits for heart failure [Срок оценки: From randomization until completion of the planned follow-up, up to 36 months]
- Time to hospitalization for heart failure [Срок оценки: From randomization until completion of the planned follow-up, up to 36 months]
- Time to urgent visits for heart failure [Срок оценки: From randomization until completion of the planned follow-up, up to 36 months]
- Time to cardiovascular death [Срок оценки: From randomization until completion of the planned follow-up, up to 36 months]
- Time to all-cause death [Срок оценки: From randomization until completion of the planned follow-up, up to 36 months]
- Time to cardiovascular hospitalization [Срок оценки: From randomization until completion of the planned follow-up, up to 36 months]
- Total number of worsening heart failure events and cardiovascular deaths [Срок оценки: From randomization until completion of the planned follow-up, up to 36 months]
- Change in quality of life - KCCQ score [Срок оценки: Baseline, 3 months, 12 months]
- Change in quality of life - MLWHFQ [Срок оценки: Baseline, 3 months, 12 months]
- Change in 6-minute walk test from baseline to Month 3 and Month 12 [Срок оценки: Baseline, 3months, 12 months]
- Change in H2FPEF score from baseline to Month 3 and Month 12 [Срок оценки: Baseline, 3 months, 12 months]
- Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) from baseline to Month 3 and Month 12 [Срок оценки: Baseline, 3 months, 12 months]
Критерии участия
Критерии включения
- Symptomatic paroxysmal or persistent atrial fibrillation
- CHADS2-VASc score≥ 2
- Conform to the diagnosis of HFpEF
- NYHA II-IV level;
- Left ventricular ejection fraction (LVEF)≥ 50%;
- NT-proBNP≥ 300 pg/mL under sinus rhythm or NT-proBNP≥ 600 pg/mL under atrial fibrillation or flutter;
- Evidence of left ventricular diastolic dysfunction/raised left ventricular filling pressure on echocardiogram.
- Sign informed consent
Критерии исключения
- A life expectancy below 2 years due to any non-cardiovascular condition
- Reversible atrial fibrillation, such as hyperthyroidism or hypokalemia-related atrial fibrillation
- Prior atrial fibrillation ablation
- Left atrial size≥ 55 mm
- Heart failure due to any of the following: known genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
- Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
- Any contraindication for radiofrequency catheter ablation, antiarrhythmic drugs or anticoagulation
- Acute coronary syndrome, cardiac surgery, angioplasty or cerebrovascular accident within 12 weeks before enrollment
- Severe hepatic and renal dysfunction
- Body mass index> 50 kg/m2
- Female in period of pregnancy or breast-feeding
- Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
- Involved in other studies
The inclusion and exclusion criteria would be reassessed after run-in period and the cut-off of NT-proBNP would be set as >125 pg/ml under sinus rhythm or >365 pg/ml under AF/atrial flutter (AFL).
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- the First Affiliated Hospital of Nanjing Medical University — Нанкин
Идентификаторы
NCT: NCT06125925 · 2023-SR-659