Evaluation of Risk Factors for Therapeutic Outcome in Patients with Tachycardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- histological characteristics
研究概览
简要总结
Decision between rate control and rhythm control can be a challenge in clinical practice. While there is some guiding evidence, we still lack a comprehensive insight into different subgroups of patients that will benefit from a rhythm control treatment.
EMPATHY is a prospective clinical study in patients presenting with heart failure and a tachyarrhythmic rhythm disturbance. Biomarkers, routinely obtained results from clinical examinations, and results from endomyocardial biopsies shall be evaluated to identify patients which have better outcome from a rhythm control strategy by ablation therapy or, if contraindicated by pharmacological rhythm control.
This study is designed to identifying risk factors and subgroups profiting from rhythm restoration and therefore improve current therapeutic approaches and the rate of recurrence-free survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed left ventricular ejection fraction ≤ 50%
- •endomyocardial biopsy available
- •tachycardic rhythm disturbance with a rhythm control strategy planned for tachycardic atrial fibrillation or flutter (≥100/min) or more than 10000 ventricular premature beats in 24 hours
排除标准
- •age <18 years
- •patient unable or unwilling to give informed consent
- •coronary artery stenosis >50%
- •relevant valvular disease
- •simultaneous contraindications against amiodarone treatment and pulmonary vein isolation/ablation therapy
- •present or suspected alcohol/drug dependency will result in exclusion from the study
结局指标
主要结局
histological characteristics
时间窗: 3 months
Identification of histopathological criteria, which indicate better outcome after rhythm control. Recovery of left ventricular ejection fraction (assessed by echocardiography) will be measured.
次要结局
- NYHA class (New York Heart Association)(3 months)
- recurrence of rhythm disturbance(3 months)
- rehospitalization(3 months)
- all-cause mortality(3 months)