McInnis Micheal C, Chow Clement T, Boutet Alexandre, Mafeld Sebastian, Granton John, McRae Karen, Donahoe Laura, de Perrot Marc
Department of Medical Imaging, University of Toronto, Toronto, ON, Canada.
Division of Respirology, Department of Medicine, University of Toronto, Toronto, ON, Canada.
Pulm Circ. 2021 Nov 18;11(4):20458940211059994. doi: 10.1177/20458940211059994. eCollection 2021 Oct-Dec.
Treatment options for chronic thromboembolic pulmonary hypertension (CTEPH) are rapidly expanding. The purpose of this study is to identify trends in CTEPH clinical trials and the publication of results. We performed a worldwide review of completed and ongoing clinical trials through searching the ClinicalTrials.gov database and the World Health Organization International Clinical Trials Registry Platform for "CTEPH" and related terms. Entries were classified as pharmaceutical/procedural interventions (Group 1), all other clinical trials (Group 2) and patient registries (Group 3). Trial characteristics and national affiliation were recorded. PubMed was searched for related publications. There were 117 clinical trials registry entries after removing duplicates and non-target records. Group 1 comprised 29 pharmaceutical, 15 procedural, and four combined interventions starting in 2005, 2010, and 2016, respectively. Riociguat and balloon pulmonary angioplasty were the most frequent pharmaceutical and procedural interventions, respectively. The proportion of procedural trials increased over time from 0% of those in 2005-2009 to 29% in 2010-2014 and 54% in 2015-2020. There were 56 entries in Group 2 and 13 in Group 3. Japan was the most frequent national affiliation and the most frequent participating country, present in 28% of all trials. The proportion of entries with published results was highest with Group 3 (62%) and lowest with Group 1 (27%). Thirty percent of all publications occurred in 2020. In conclusion, CTEPH clinical trials are increasingly procedural based, with growth largely attributable to Japan and balloon pulmonary angioplasty. Most trials have not published, but results from balloon pulmonary angioplasty clinical trials are anticipated soon.
慢性血栓栓塞性肺动脉高压(CTEPH)的治疗选择正在迅速增加。本研究的目的是确定CTEPH临床试验及结果发表的趋势。我们通过在ClinicalTrials.gov数据库和世界卫生组织国际临床试验注册平台中搜索“CTEPH”及相关术语,对已完成和正在进行的临床试验进行了全球范围的综述。条目被分为药物/程序干预(第1组)、所有其他临床试验(第2组)和患者登记(第3组)。记录了试验特征和国家所属情况。在PubMed中搜索相关出版物。去除重复和非目标记录后,有117条临床试验注册条目。第1组包括29项药物干预、15项程序干预和4项联合干预,分别始于2005年、2010年和2016年。利奥西呱和球囊肺动脉成形术分别是最常见的药物和程序干预。程序试验的比例随时间增加,从2005 - 2009年的0%增至2010 - 2014年的29%,以及2015 - 2020年的54%。第2组有56条条目,第3组有13条条目。日本是最常见的国家所属和参与国家,占所有试验的28%。结果已发表条目的比例在第3组最高(62%),在第1组最低(27%)。所有出版物的30%出现在2020年。总之,CTEPH临床试验越来越以程序为基础,增长主要归因于日本和球囊肺动脉成形术。大多数试验尚未发表,但球囊肺动脉成形术临床试验的结果预计很快会公布。