Inaguma Daijo, Sasakawa Yuji, Suzuki Noriko, Ito Eri, Takahashi Kazuo, Hayashi Hiroki, Koide Shigehisa, Hasegawa Midori, Yuzawa Yukio
Department of Nephrology, Fujita Health University, Toyoake, Aichi, Japan.
Mizuno Clinic, Toyoake, Aichi, Japan.
BMC Nephrol. 2018 Apr 3;19(1):80. doi: 10.1186/s12882-018-0877-6.
Aortic stenosis (AS) is common in patients on dialysis as well as in the general population. AS leads to difficulty with dialysis therapy because of unstable conditions such as intradialytic hypotension due to low cardiac output. However, the precise morbidity rates and risk factors of AS in patients on dialysis are unknown. Moreover, there are no large-scale observational studies regarding the association between AS in patients on dialysis and mortality. Therefore, we will investigate whether morbidity of AS in patients on dialysis is associated with mortality.
This is a multicenter prospective cohort analysis in the Tokai region of Japan. The 75 participating centers in this study will enroll approximately 2400 patients during 12 months, with or without AS. We started enrollment in July 2017 and will follow patents until June 2023. Transthoracic echocardiography will be performed to evaluate aortic valve. Parameters used for evaluation of aortic valve are mean pressure gradient between left ventricle and ascending aorta, aortic valve area, and maximum aortic jet velocity. We will diagnose AS using the criteria based on the 2014 American Heart Association/ American College of Cardiology Guideline. We will also perform transthoracic echocardiography at 12, 24, 36, 48, and 60 months. Survival prognosis and CV events will be determined at the end of June 2019, 2020, 2021, 2022, and 2023. Development of AS will be also evaluated as new onset or annual change in AS parameters. We will classify patients based on the presence or absence of AS and the stages of AS and will compare outcomes. Study outcomes will include the following: 1) all-cause mortality rates; 2) incidence of cardiovascular (CV) events; 3) CV-related mortality rates; 4) infection-related mortality rates; 5) new onset or development of AS.
We will consider the following hypotheses in this study, among others: The prevalence of AS is higher in dialysis patients; new onset and development of AS are associated with factors that are specific for dialysis, such as hyperphosphatemia, hyperparathyroidism, and medication; and outcomes in AS patients are poorer than in patients without AS at baseline.
UMIN000026756 , Registered March 29 2017.
主动脉瓣狭窄（AS）在透析患者以及普通人群中都很常见。由于诸如心输出量低导致的透析中低血压等不稳定状况，AS会给透析治疗带来困难。然而，透析患者中AS的确切发病率和危险因素尚不清楚。此外，关于透析患者的AS与死亡率之间的关联，尚无大规模观察性研究。因此，我们将调查透析患者中AS的发病率是否与死亡率相关。
这是一项在日本东海地区进行的多中心前瞻性队列分析。本研究中的75个参与中心将在12个月内招募约2400名患者，无论其是否患有AS。我们于2017年7月开始招募，并将对患者进行随访直至2023年6月。将进行经胸超声心动图检查以评估主动脉瓣。用于评估主动脉瓣的参数包括左心室与升主动脉之间的平均压力阶差、主动脉瓣面积以及最大主动脉血流速度。我们将根据2014年美国心脏协会/美国心脏病学会指南的标准来诊断AS。我们还将在第12、24、36、48和60个月时进行经胸超声心动图检查。生存预后和心血管事件将在2019年、2020年、2021年、2022年和2023年6月底确定。AS的发生情况也将作为AS参数的新发或年度变化来评估。我们将根据是否存在AS以及AS的阶段对患者进行分类，并比较结果。研究结果将包括以下内容：1）全因死亡率；2）心血管（CV）事件的发生率；3）CV相关死亡率；4）感染相关死亡率；5）AS的新发或进展情况。
在本研究中，我们将考虑以下假设，其中包括：透析患者中AS的患病率更高；AS的新发和进展与透析特有的因素相关，如高磷血症、甲状旁腺功能亢进和药物治疗；基线时，AS患者的预后比无AS患者更差。
UMIN000026756，于2017年3月29日注册。
