Department of Cardiology, Zhengzhou University People's Hospital, Zhengzhou, Henan 450003, China.
Department of Cardiology, Zhengzhou University People's Hospital, Zhengzhou, Henan 450003, China.
Int J Cardiol. 2018 Mar 1;254:210-214. doi: 10.1016/j.ijcard.2017.12.025. Epub 2017 Dec 15.
No uniform diagnostic criteria have been developed for heart failure with preserved ejection fraction (HFpEF), resulting in huge discrepancies in the patient recruitments of HFpEF trials. This study aims to assess the quality of inclusion criteria in HFpEF trials.
We systematically searched the International Clinical Trials Registry Platform for HFpEF trials and extracted the basic characteristics and inclusion criteria. We then scored and compared the quality of inclusion criteria using an adapted 5-point scoring system of ejection fraction (EF), symptoms, signs, natriuretic peptides and other tests.
A total of 121 trials and 19,494 patients were finally included for statistical analyses. More than half (67/121, 55.4%) of the trials employed 50% as the cut-off value for diagnosing HFpEF. Symptoms (102/121, 84.3%) are mostly provided by trial registrars, followed by natriuretic peptides (46/121, 38.0%) and signs (32/121, 26.4%). Average total scores of inclusion criteria wavily increased from 2.00 in 2002 to 3.00 in 2016 (P=0.04). Interventional trials were not significantly different from observational trials (3.00±1.18 vs. 2.75±1.53, P=0.45), but ongoing trials were higher in total score than completed trials (3.28±1.24 vs. 2.72±1.17, P=0.01). Published trials were not significantly different from the unpublished trials at registration (2.76±1.13 vs. 2.69±1.20, P=0.82), but their total scores significantly increased to 3.48±0.96 at publication (P<0.01).
The qualities of inclusion criteria are heterogeneous and significantly improved with time in registered HFpEF clinical trials. EF, symptoms and signs should be specified at trial registration to make a more reliable diagnosis and to recruit a more homogenous population.
射血分数保留型心力衰竭（HFpEF）缺乏统一的诊断标准，导致 HFpEF 临床试验的患者纳入存在巨大差异。本研究旨在评估 HFpEF 临床试验纳入标准的质量。
我们系统地检索了国际临床试验注册平台上的 HFpEF 试验，并提取了基本特征和纳入标准。然后，我们使用改良的 5 分射血分数（EF）、症状、体征、利钠肽和其他检查点评分系统对纳入标准的质量进行评分和比较。
共纳入 121 项试验和 19494 例患者进行统计学分析。超过一半（67/121，55.4%）的试验采用 50%作为 HFpEF 诊断的截断值。症状（102/121，84.3%）主要由试验登记员提供，其次是利钠肽（46/121，38.0%）和体征（32/121，26.4%）。纳入标准的总分从 2002 年的 2.00 分波动增加到 2016 年的 3.00 分（P=0.04）。干预试验与观察性试验之间没有显著差异（3.00±1.18 与 2.75±1.53，P=0.45），但正在进行的试验总分高于已完成的试验（3.28±1.24 与 2.72±1.17，P=0.01）。发表的试验与注册时未发表的试验没有显著差异（2.76±1.13 与 2.69±1.20，P=0.82），但发表后总分显著增加至 3.48±0.96（P<0.01）。
HFpEF 临床试验纳入标准的质量存在差异，且随时间推移显著提高。EF、症状和体征应在试验登记时明确，以做出更可靠的诊断并招募更同质的人群。
