Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias At the University Heart Center Hamburg
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- New onset of cardiac arrhythmias, documented in clinical care and during systematic rhythm monitoring using digital devices.
研究概览
简要总结
The "Long-term Outcome and Predictors for Recurrence after Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg" (TRUST) study is an investor-initiated, single-center, prospective clinical cohort study including patients treated with cardiac arrhythmias or at high risk for cardiac arrhythmias. The design enables prospective, low-threshold, near complete inclusion of patients with arrhythmias treated at the UHZ. Collection of routine follow-up data, detailed procedural information and systematic biobanking will enable precise and robust phenotyping.
详细描述
Arrhythmias such as atrial fibrillation, ventricular tachycardia, and sudden death remain major causes of morbidity and mortality. Their prevalence increases in our ageing populations. Modern therapy of these conditions, using a combination of drugs, devices, and interventions, can reduce the disease burden associated with cardiac arrhythmias. This prospective cohort study will collect detailed clinical, procedural, and outcome information in a large cohort of patients with arrhythmias seen in a tertiary care center. Clinical phenotyping will be enhanced by biosampling and analysis of circulating biomolecules. Digital capture of clinical information and of follow-up data is planned.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Cardiac arrhythmia, including congenital cardiac arrhythmia diagnosed at baseline or high risk for cardiac arrhythmia
- •Age ≥ 18 years
- •Written informed consent
- •Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
排除标准
- •Insufficient knowledge of the German language to understand study documents and interview without translation
- •Physical or psychological incapability to cooperate in the investigation
结局指标
主要结局
New onset of cardiac arrhythmias, documented in clinical care and during systematic rhythm monitoring using digital devices.
时间窗: Follow-up 5 years after inclusion
The outcome is measured via remote follow-up using consumer-electronics based remote rhythm monitoring technologies. Additionally, onset of new cardiac arrhythmias is assessed from medical records collected between follow-up timepoint and inclusion as well as questionnaires and a telephone call with the patient.
Time to a composite of cardiovascular mortality, stroke, acute coronary syndrome and heart failure hospitalization
时间窗: Follow-up 5 years after inclusion
The main primary outcome measures the time until any of death from cardiovascular cause, stroke or TIA or a hospitalization due to heart failure or acute coronary syndrome occurs for the first time after inclusion. The outcome is measured via telephone and / or in-person follow-up, acquisition of all relevant medical records between inclusion and follow-up timepoint and a questionnaire sent to the patient. The follow-up can be completed fully electronically according to patient's wish.
次要结局
- New onset of heart failure(Follow-up 5 years after inclusion)
- Patient reported quality of life (QOL)(Follow-up 5 years after inclusion)
- Complications of rhythm control therapy (Safety Outcome)(Follow-up 5 years after inclusion)
- All-cause mortality (Safety Outcome)(Follow-up 5 years after inclusion)
- Time to recurrence of the clinical arrhythmia(Follow-up 5 years after inclusion)
- Health care utilisation(Follow-up 5 years after inclusion)