The Current Focus of Heart Failure Clinical Trials.

The Current Focus of Heart Failure Clinical Trials.
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DOI:
10.1016/j.cardfail.2018.02.006
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发表时间:
2018-05
影响因子:
6
通讯作者:
Kenchaiah S
Kenchaiah S
中科院分区:
医学2区
文献类型:
--
作者:
Pothineni NV;Kattoor AJ;Kovelamudi S;Kenchaiah S

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心力衰竭(HF)是一个主要的全球健康问题。临床试验测试了治疗心力衰竭的新疗法的有效性、有效性和安全性。我们试图确定正在进行的心衰介入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注册中心和世界卫生组织的国际临床试验注册平台,提取了当前HF临床试验的相关信息进行系统审查。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%)由企业赞助,三分之一(35.6%)由大学赞助。NIH和其他美国联邦机构只资助了14项试验(占所有试验的1.8%;占美国试验的10.7%)。在536个有特定左心室射血分数状态的HF试验中,434个(81.0%)试验集中在射血分数(HFrEF)降低的HF,而只有102个(19.0%)试验以射血分数(HFpEF)保留的HF为目标。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,但与HFrEF相比,针对HFpEF的临床试验数量要少得多。
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.
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