顽固性高血压 开放性、复杂性(“Cum Plicare”)或复杂性(“Cum Plexus”)综合征?
顽固性高血压 开放性、复杂性(“Cum Plicare”)或复合型(“Cum Plexus”)
研究概览
详细说明
文献 41-44 中描述了脉搏间隔(心率变异性)和收缩压变异性频谱分析的心血管自主调节程序。 每次心跳都将使用 Matlab MT 软件(MATLAB 6.0,Mathworks,美国)中实现的专用算法进行识别,该算法会自动检测 PAS 和 PAD 波。 脉冲间隔或 R-R 间隔将计算为周期开始点和结束点 (t1-t0) 之间的差值。 PAS 和 R-R 间隔的功率谱密度将使用快速傅里叶变换和 Welch 方法计算,涵盖 16,384 个点,具有汉宁窗和 50% 重叠。 针对人类评估的光谱带是根据参考文献定义的:极低频(MBF:0.007-0.04Hz), 低频(BF:0.04-0.15Hz), 高频(AF:0. 15-0.4 Hz)和全功率[130]。 压力反射敏感性将从 α 指数(以 ms2 为单位的 HR BF 比率/以 mmHg 为单位的 SBP BF 比率)推断。
ABPM - 它将使用 CardioMAPA 监视器 - Cardios - 巴西进行,在清醒期间每 15 分钟进行一次标准化测量,在睡眠期间每 20 分钟进行一次标准化测量。 当监测时间至少为 21 小时、清醒期间至少进行 40 次测量、睡眠期间至少进行 10 次测量时,数据将被视为有效。
中心血压和放大指数 (AIx) 的测定 - SphygmoCor CPV 系统(AtCor Medical,美国)是一种先进的非侵入性诊断工具,用于临床评估中心血压。 该系统利用桡动脉记录的脉搏波压力得出中央主动脉脉搏波压力(收缩压、舒张压和脉搏)。 脉搏波分析可预测参数,包括 PAC 和血管僵硬度指标。 使用放置在所需动脉中的压力传感器(眼压计)进行测量,然后记录脉搏波。 此外,该设备通过分析增强指数[放大指数(AIx)]来提供动脉僵硬度的信息,增强指数由反射波和能够提供动脉僵硬度信息的射血波确定的压力之间的比率定义。
临床参数评估 - 将根据第八版巴西动脉高血压指南的建议,使用数字血压计 (Omron HEM-711DLX) 进行血压测量。 脉压 (PP) 将根据收缩压 (SBP) 和舒张压 (DBP) 值之间的差值计算。 所有个人都将使用 Spacelabs 90217 设备(Spacelabs Inc,雷德蒙,华盛顿州,美国)接受 24 小时的动态血压监测 (ABPM)。 将指导患者保持并记录正常的日常活动。 将评估 SBP、DBP 和 PP 的平均值。
生化和炎症参数评估 - 将收集空腹血样并进行以下测试:葡萄糖、糖化血红蛋白 A1C、总胆固醇和分数、尿素、肌酐、肾素、醛固酮、皮质醇、肌酐清除率和微量白蛋白尿。 生物标志物去甲肾上腺素、多巴胺、肾上腺素、促肾上腺皮质激素 (ACTH) 和皮质醇、乙酰胆碱酯酶、超敏 C 反应蛋白、白细胞介素 2、8、10 和 12(IL-2、IL-8、IL-10 和 IL-12)将根据制造商的说明通过 ELISA 测定。
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:TATIANE DE AZEVEDO RUBIO
- 电话号码:+55(17)991422510
- 邮箱:thatyazevedo@gmail.com
学习地点
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SP
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Votuporanga、SP、巴西、15505185
- 招聘中
- Tatiane de Azevedo Rubio
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接触:
- TATIANE DE AZEVEDO RUBIO
- 电话号码:+55(17)991422510
- 邮箱:thatyazevedo@gmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
纳入标准:
1)根据最新的国际和国家指南,被诊断为难治性动脉高血压(RH)的35岁以上男性和女性; 2)能够理解、表达和回答问题; 3)同意参加本研究并签署知情同意书; 4)了解清楚后; 5) 在UNICAMP心血管药理门诊定期随访至少六个月; 5) 已证明能够坚持非药物和药物治疗; 7)处于生育期的妇女必须使用经证实有效的避孕方法。
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排除标准:
1)有心力衰竭的临床病史或临床症状; 2)扩张型心肌病、瓣膜性心脏病、心包疾病患者; 3)患有脑血管疾病或周围动脉疾病、肾病、肝病、吸烟、自身免疫性疾病和使用违禁药物的患者; 4) 经研究者判断可能干扰研究结果或志愿者健康的任何异常情况; 5) 已怀孕或拟怀孕的妇女; 6) 目前正在参与另一项调查研究; 7) 重度抑郁症或其他相关精神疾病。
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学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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血压正常 - 显然健康
非高血压参与者组
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研究中不会有任何干预。
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控制高血压
被诊断患有原发性高血压并接受门诊随访的参与者
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研究中不会有任何干预。
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顽固性高血压
使用 3 种或更多抗高血压药物诊断患有原发性动脉高血压的参与者,其中一种最好是噻嗪类利尿剂
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研究中不会有任何干预。
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难治性高血压
使用 5 种或更多抗高血压药物诊断患有原发性动脉高血压的参与者。
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研究中不会有任何干预。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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血压
大体时间:4周
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通过 MAPA 使用混沌理论的非线性计算
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4周
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心率
大体时间:4周
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通过 MAPA 使用混沌理论的非线性计算
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4周
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TNF-α水平
大体时间:10周
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与血压变异性相关的炎症反应分析
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10周
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IL1β、IL-6 水平
大体时间:10周
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与血压变异性相关的炎症反应分析
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10周
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合作者和调查者
出版物和有用的链接
一般刊物
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- Ritter AM, de Faria AP, Barbaro N, Sabbatini AR, Correa NB, Brunelli V, Amorim R, Modolo R, Moreno H. Crosstalk between obesity and MMP-9 in cardiac remodelling -a cross-sectional study in apparent treatment-resistant hypertension. Blood Press. 2017 Apr;26(2):122-129. doi: 10.1080/08037051.2016.1249336. Epub 2016 Nov 8.
- de Haro Moraes C, Figueiredo VN, de Faria AP, Barbaro NR, Sabbatini AR, Quinaglia T, Ferreira-Melo SE, Martins LC, Demacq C, Junior HM. High-circulating leptin levels are associated with increased blood pressure in uncontrolled resistant hypertension. J Hum Hypertens. 2013 Apr;27(4):225-30. doi: 10.1038/jhh.2012.29. Epub 2012 Jul 19.
- Faria AP, Ritter AMV, Gasparetti CS, Correa NB, Brunelli V, Almeida A, Pires NF, Modolo R, Moreno Junior H. A Proposed Inflammatory Score of Circulating Cytokines/Adipokines Associated with Resistant Hypertension, but Dependent on Obesity Parameters. Arq Bras Cardiol. 2019 Apr;112(4):383-389. doi: 10.5935/abc.20190032. Epub 2019 Feb 28.
- Ritter AM, Fontana V, Faria AP, Modolo R, Barbaro NR, Sabbatini AR, Peres H, Biagi C, Silva PS, Lopes PC, Tanus-Santos JE, Coelho EB, Moreno H. Association of Mineralocorticoid Receptor Polymorphism I180V With Left Ventricular Hypertrophy in Resistant Hypertension. Am J Hypertens. 2016 Feb;29(2):245-50. doi: 10.1093/ajh/hpv070. Epub 2015 Jun 6.
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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