Optimizing the Management of Heart Failure With Preserved Ejection Fraction in the Elderly by Targeting Comorbidities (OPTIMIZE-HFPEF)
Optimizing the Management of Heart Failure With Preserved Ejection Fraction in the Elderly by Targeting Comorbidities (OPTIMIZE-HFPEF)
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DOI：
10.1016/j.cardfail.2016.01.011
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发表时间：
2016-07-01
影响因子：
6
通讯作者：
Andersson, Bert
中科院分区：
文献类型：
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作者：
Fu, Michael;Zhou, Jingmin;Andersson, Bert
目的：射血分数保留的心力衰竭(HFPEF)的病理生理机制尚不完全清楚。最近提出的HFPEF的机制是，它是一种由共病引起的全身性促炎状态，导致微血管内皮细胞功能障碍和随后的心脏重构和功能障碍。我们假设，靶向合并症将改善HFPEF老年患者的预后。因此，这项研究的目的是确定系统筛查和优化处理与HFPEF相关的预先指定的合并症是否会改善结果。方法：这项多中心、前瞻性、随机干预试验使用了一种开放的程序，对终点进行盲法评估。60岁的HFPEF患者(n=360)将被随机1：1分配到试验的常规护理或干预组。当被随机分配到干预组时，所有患者都将接受系统筛查，并对最常见的心血管、代谢、呼吸系统和肾脏合并症进行最佳治疗。主要终点是综合临床评分，根据客观和主观数据将每个随机分组的患者分类为改善或恶化，由盲目终点委员会进行24个月的随访。结论：我们的研究旨在为HFPEF管理中可能的范式转变提供证据，而不是针对心功能障碍。我们的新概念侧重于将合并症作为HFPEF的诱因进行管理。
Aims: The pathophysiology of heart failure with preserved ejection fraction (HFPEF) is not fully understood. A recently proposed mechanism for HFPEF is that it is a systemic pro-inflammatory state induced by comorbidities, leading to microvascular endothelial dysfunction and subsequent cardiac remodeling and dysfunction. We hypothesize that targeting comorbidities will improve outcomes in elderly patients with HFPEF. Thus, the aim of this study is to determine whether the combination of systematic screening and optimal management of prespecified comorbidities associated with HFPEF improves outcomes.Methods: This multicenter, prospective, randomized intervention trial uses an open procedure with blinded endpoint assessment. Patients with HFPEF aged >60 years (n = 360) will be randomized 1:1 to the usual care or intervention arm of the trial. When randomized to the intervention arm, all patients will be systematically screened and optimally treated for the most frequent cardiovascular, metabolic, respiratory, and renal comorbidities. The primary endpoint is a composite clinical score that classifies each randomized patient as improved or deteriorated based on objective and subjective data at a 24-month follow-up performed by a blinded endpoint committee.Conclusion: Rather than targeting cardiac dysfunction, our study aims to present evidence for a possible paradigm shift in the management of HFPEF. Our novel concept focuses on the management of comorbidities as predisposing factors in HFPEF.