Division of Cardiovascular Medicine, Department of Internal Medicine, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
Division of Cardiovascular Medicine, Department of Internal Medicine, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas; Zena and Michael A. Weiner Cardiovascular Institute, Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, New York, New York.
J Card Fail. 2018 May;24(5):321-329. doi: 10.1016/j.cardfail.2018.02.006. Epub 2018 Mar 2.
Heart failure (HF) is a major global health problem. Clinical trials test efficacy, effectiveness, and safety of novel and emerging therapies in HF. We sought to determine the salient features of ongoing interventional clinical trials in HF.
We accessed the ClinicalTrials.gov registry of the National Institutes of Health (NIH) and the International Clinical Trials Registry Platform of the World Health Organization on January 1, 2017, and extracted pertinent information on current HF clinical trials for systematic review. Of 794 HF trials that met our inclusion criteria, almost one-half (49.1%) evaluated clinical end points and one-third (32.8%) examined imaging end points as primary outcomes. One-fourth (24.8%) were industry sponsored and one-third (35.6%) were university sponsored. The NIH and other United States federal agencies funded only 14 trials (1.8% of all trials; 10.7% of trials in the US). Among 536 HF trials with specified left ventricular ejection fraction status, 434 (81.0%) focused on HF with reduced ejection fraction (HFrEF) and only 102 (19.0%) trials targeted HF with preserved ejection fraction (HFpEF).
Ongoing HF trials are predominantly sponsored by nongovernmental funding agencies. Although HFpEF occurs as commonly as HFrEF in the community, the number of clinical trials targeting HFpEF is substantially lower compared with HFrEF.
心力衰竭（HF）是一个全球性的主要健康问题。临床试验测试新出现的HF 治疗方法的疗效、效果和安全性。我们试图确定 HF 干预性临床试验的显著特征。
我们于 2017 年 1 月 1 日访问了美国国立卫生研究院（NIH）的 ClinicalTrials.gov 注册处和世界卫生组织的国际临床试验注册平台，并提取了有关 HF 临床试验的系统评价的相关信息。在符合我们纳入标准的 794 项 HF 试验中，近一半（49.1%）评估了临床终点，三分之一（32.8%）检查了成像终点作为主要结果。四分之一（24.8%）为工业赞助，三分之一（35.6%）为大学赞助。NIH 和其他美国联邦机构仅资助了 14 项试验（所有试验的 1.8%；美国试验的 10.7%）。在 536 项明确规定左心室射血分数状态的 HF 试验中，434 项（81.0%）集中于射血分数降低的心力衰竭（HFrEF），仅有 102 项（19.0%）试验针对射血分数保留的心力衰竭（HFpEF）。
正在进行的 HF 试验主要由非政府资助机构赞助。尽管 HFpEF 在社区中与 HFrEF 一样常见，但针对 HFpEF 的临床试验数量明显低于 HFrEF。
