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房颤治疗知情选择结局注册研究:ORBIT-AF 的研究背景和设计。

Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF.

机构信息

Duke Clinical Research Institute, Durham, NC, USA.

出版信息

Am Heart J. 2011 Oct;162(4):606-612.e1. doi: 10.1016/j.ahj.2011.07.001.

DOI:10.1016/j.ahj.2011.07.001
PMID:21982650
Abstract

BACKGROUND

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with an increased risk of stroke, heart failure, and death. Data on contemporary treatment patterns and outcomes associated with AF in clinical practice are limited.

METHODS/DESIGN: The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation is a multicenter, prospective, ambulatory-based registry of incident and prevalent AF. The registry will be a nationwide collaboration of health care providers, including internists, primary care physicians, cardiologists, and electrophysiologists. Initial target enrollment is approximately 10,000 patients to be recruited from approximately 200 US outpatient practices. Enrolled patients will be observed for ≥2 years. A patient-reported outcomes substudy in ≥1,500 patients will provide serial quality-of-life assessments. The goal is to characterize treatment and outcomes of patients with AF, thereby promoting better quality of AF care and improved patient outcomes.

CONCLUSION

The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation will provide insights into "real-world" treatment including rate and rhythm control, stroke prevention, transitions to new therapies, and clinical and patient-centered outcomes among patients with AF in community practice settings (ClinicalTrials.gov NCT01165710).

摘要

背景

心房颤动(AF)是最常见的持续性心律失常,与中风、心力衰竭和死亡风险增加有关。关于临床实践中与 AF 相关的当代治疗模式和结局的数据有限。

方法/设计:更好地了解心房颤动治疗的结局注册是一项多中心、前瞻性、基于门诊的新发和现患心房颤动注册研究。该注册将是一个由医疗保健提供者(包括内科医生、初级保健医生、心脏病专家和电生理学家)组成的全国性合作。最初的目标入组人数约为 10000 名患者,将从大约 200 个美国门诊实践中招募。入组患者将被观察至少 2 年。在≥1500 名患者中进行的患者报告结局亚研究将提供连续的生活质量评估。其目标是描述 AF 患者的治疗和结局,从而提高 AF 护理质量并改善患者结局。

结论

更好地了解心房颤动治疗的结局注册将提供关于“真实世界”治疗的见解,包括节律和心率控制、中风预防、向新疗法的转变以及社区实践环境中 AF 患者的临床和以患者为中心的结局(ClinicalTrials.gov NCT01165710)。

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