Department of Cardiovascular Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Nutritional Sciences, Pennsylvania State University, University Park, Pennsylvania, USA.
BMJ Open. 2022 May 2;12(5):e049225. doi: 10.1136/bmjopen-2021-049225.
The evidence on predictive value of lifestyle behaviours and dietary pattern on the prognosis of heart failure (HF) is limited. Our aim is to identify these factors in the setting of secondary prevention of HF.
The Metabolic Abnormalities, Lifestyle and Dietary Pattern in Heart Failure study is an ongoing, prospective cohort, single-centre study that aims to recruit 1500 patients with HF from June 2016 to June 2021. At baseline, each participant completes a questionnaire on demographic characteristics, medical history, lifestyle behaviours, sleep duration and quality, bowel movements and regular diet. Biochemical measurements, blood pressure, carotid ultrasound, echocardiography, electrocardiography and cardiac magnetic resonance are obtained and analysed. Muscle strength is assessed using the handgrip dynamometer and the MicroFet2 hand-held dynamometer. Each patient is followed for 5 years or until the occurrence of death. The primary outcome is a composite of cardiovascular mortality or hospitalisation due to worsening heart failure. The secondary end points are cardiovascular deaths and the hospitalisations due to worsening HF. The incidence of mortality and cardiovascular events is documented biennially.
The study protocol has been approved by the Ethics Committee of the Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and follows the norms of the World's Association Declaration of Helsinki. The results of this study will be disseminated in peer-reviewed journals and academic conferences.
NCT03951311.
生活方式行为和饮食模式对心力衰竭（HF）预后的预测价值的证据有限。我们的目的是在 HF 的二级预防中确定这些因素。
代谢异常、生活方式和饮食模式在心力衰竭研究是一项正在进行的、前瞻性队列、单中心研究，旨在从 2016 年 6 月至 2021 年 6 月招募 1500 名 HF 患者。在基线时，每位参与者完成一份关于人口统计学特征、病史、生活方式行为、睡眠时长和质量、排便和规律饮食的问卷。进行生化测量、血压、颈动脉超声、超声心动图、心电图和心脏磁共振检查并进行分析。使用握力计和 MicroFet2 手持测力计评估肌肉力量。每位患者随访 5 年或直至发生死亡。主要结局是心血管死亡率或因心力衰竭恶化而住院的复合结局。次要终点是心血管死亡和因心力衰竭恶化而住院。每两年记录一次死亡率和心血管事件的发生率。
该研究方案已获得上海交通大学医学院瑞金医院伦理委员会的批准，并遵循世界医学协会赫尔辛基宣言的规范。这项研究的结果将在同行评议的期刊和学术会议上发表。
NCT03951311。
