Charitakis Emmanouil, Walfridsson Ulla, Nyström Fredrik, Nylander Eva, Strömberg Anna, Alehagen Urban, Walfridsson Håkan
Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
Department of Medical and Health Sciences, Faculty of Health Sciences, Linköping University, Linköping, Sweden.
BMJ Open. 2015 Dec 21;5(12):e008723. doi: 10.1136/bmjopen-2015-008723.
Atrial fibrillation (AF) is the most common cardiac arrhythmia, with an estimated prevalence of 1.5-2%. It is an independent risk factor for ischaemic stroke and is estimated to cause about 20-25% of all stroke cases. AF has a great impact on health-related quality of life (HRQoL); however, one unresolved issue related to AF is the wide variation in its symptoms.
The symptom burden, metabolic profile, ultrasound findings, rhythm, neurohormonal activation, haemodynamics and HRQoL in patients with AF (Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal activation, haemodynamics and health-related quality of life in patients with atrial Fibrillation, SMURF) study is a prospective observational, cohort study, with a randomised interventional part. The aim of the study is to investigate, in patients with AF, the relationship between symptom burden and metabolic aspects, atrial function and different neurohormones, and the effect of radiofrequency ablation (RFA). The interventional part of the study will give an insight into the neurohormonal and intracardiac pressure changes directly after initiation of AF. Consecutive patients with symptomatic AF accepted for treatment with RFA for the first time at Linköping University Hospital are eligible for participation. The enrolment started in January 2012, and a total of 200 patients are to be included into the study, with 45 of them being enrolled into the interventional study with initiation of AF. The sample size of the interventional study is based on a small pilot study with 5 patients induced to AF while 2 served as controls. The results indicated that, in order to find a statistically significant difference, there was a need to include 28 patients; for safety reasons, 45 patients will be included.
The SMURF study is approved by the Regional Ethical Review Board at the Faculty of Health Sciences, Linköping, Sweden. The results will be presented through peer-review journals and conference presentation.
NCT01553045; Pre-results.
心房颤动（AF）是最常见的心律失常，估计患病率为1.5%-2%。它是缺血性卒中的独立危险因素，估计导致所有卒中病例的20%-25%。AF对健康相关生活质量（HRQoL）有很大影响；然而，与AF相关的一个未解决问题是其症状的广泛差异。
心房颤动患者的症状负担、代谢谱、超声检查结果、心律、神经激素激活、血流动力学和健康相关生活质量（Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal activation, haemodynamics and health-related quality of life in patients with atrial Fibrillation, SMURF）研究是一项前瞻性观察性队列研究，包含随机干预部分。该研究的目的是调查AF患者症状负担与代谢方面、心房功能和不同神经激素之间的关系，以及射频消融（RFA）的效果。研究的干预部分将深入了解AF发作后直接的神经激素和心内压力变化。首次在林雪平大学医院接受RFA治疗的有症状AF连续患者有资格参与。入组于2012年1月开始，共200名患者将纳入该研究，其中45名患者将纳入AF发作时的干预性研究。干预性研究的样本量基于一项小型试点研究，该研究诱导5名患者发生AF，2名作为对照。结果表明，为了发现统计学上的显著差异，需要纳入28名患者；出于安全考虑，将纳入45名患者。
SMURF研究已获得瑞典林雪平健康科学学院区域伦理审查委员会的批准。研究结果将通过同行评审期刊和会议报告进行展示。
NCT01553045；预结果。
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