Introduction Patients with heart failure (HF) are classically categorised by left ventricular ejection fraction (LVEF). Efforts to predict outcomes and response to specific therapy among LVEF-based groups may be suboptimal, in part due to the underlying heterogeneity within clinical HF phenotypes. A multidimensional characterisation of ambulatory patients with and without HF across LVEF groups is needed to better understand and manage patients with HF in a more precise manner. Methods and analysis To date, the first cohort of 1313 out of total planned 3000 patients with and without HF has been enroled in this single-centre, longitudinal observational cohort study. Baseline and 1-year follow-up blood samples and clinical characteristics, the presence and duration of comorbidities, serial laboratory, echocardiographic data and images and therapy information will be obtained. HF diagnosis, aetiology of disease, symptom onset and clinical outcomes at 1 and 5 years will be adjudicated by a team of clinicians. Clinical outcomes of interest include all-cause mortality, cardiovascular mortality, all-cause hospitalisation, cardiovascular hospitalisation, HF hospitalisation, right-sided HF and acute kidney injury. Results from the Preserved versus Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Patients with Heart Failure (PREFER-HF) trial will examine longitudinal clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand HF phenotypes, with the ultimate goal of improving precision medicine and clinical outcomes for patients with HF. Ethics and dissemination Information gathered in this research will be published in peer-reviewed journals. Written informed consent for PREFER-HF was obtained from all participants. All study procedures were approved by the Mass General Brigham Institutional Review Board in Boston, Massachusetts and performed in accordance with the Declaration of Helsinki (Protocol Number: 2016P000339). Trial registration number PREFER-HF ClinicalTrials.gov identifier: [NCT03480633][1]. All data relevant to the study are included in the article or uploaded as supplementary information. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03480633&atom=%2Fopenhrt%2F8%2F2%2Fe001704.atom

中文翻译：

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心力衰竭门诊患者保留与降低射血分数生物标志物登记和精准医学数据库 (PREFER-HF) 研究的基本原理和设计


简介 心力衰竭 (HF) 患者通常根据左心室射血分数 (LVEF) 进行分类。在基于 LVEF 的群体中预测结果和对特定治疗的反应可能不是最理想的，部分原因是临床心力衰竭表型中潜在的异质性。需要对 LVEF 组中患有和不患有心力衰竭的门诊患者进行多维特征分析，以便以更精确的方式更好地了解和管理心力衰竭患者。方法和分析 迄今为止，这项单中心、纵向观察性队列研究已纳入第一批计划的 3000 名患有或不患有心力衰竭的患者中的 1313 名患者。将获得基线和 1 年随访血液样本和临床特征、合并症的存在和持续时间、系列实验室、超声心动图数据和图像以及治疗信息。心力衰竭的诊断、疾病病因、症状出现以及 1 年和 5 年的临床结果将由临床医生团队进行裁决。感兴趣的临床结局包括全因死亡率、心血管死亡率、全因住院、心血管住院、心力衰竭住院、右侧心力衰竭和急性肾损伤。心力衰竭门诊患者的保留与射血分数减少生物标志物注册和精准医学数据库 (PREFER-HF) 试验的结果将检查纵向临床特征、蛋白质组学、代谢组学、基因组和影像数据，以更好地了解心力衰竭表型，最终目标改善心力衰竭患者的精准医疗和临床结果。道德与传播 本研究中收集的信息将发表在同行评审的期刊上。 所有参与者均获得了 PREFER-HF 的书面知情同意书。所有研究程序均得到马萨诸塞州波士顿麻省总医院布里格姆机构审查委员会的批准，并根据赫尔辛基宣言进行（方案编号：2016P000339）。试验注册号 PREFER-HF ClinicalTrials.gov 标识符：[NCT03480633][1]。与研究相关的所有数据都包含在文章中或作为补充信息上传。 [1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03480633&atom=%2Fopenhrt%2F8%2F2%2Fe001704。原子