Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs. (CLIN-HTN-PD)
2021年11月15日 更新者：Kathryn Anne Chung、Oregon Health and Science University
Current management of hypertension in PD motor fluctuators is flawed.
The current practice often is to treat transient hypertensive spikes reported by patients or measured in clinics with anti-hypertensive medications.
This may contribute to morbidity by worsening orthostatic hypotension and increasing fall risk.
There is a scarcity of literature on this subject and there is no documentation of severe hypertension with rises in systolic blood pressure exceeding 50% of baseline occurring during motor "OFF".
There are two studies that have demonstrated that blood pressure fluctuation can occur in motor fluctuators during the "OFF" state1,2.
The study by Baratti et al measured blood pressure in 13 Parkinson's disease patients, 7 with motor fluctuations and 6 without fluctuations.
In the fluctuators, the mean systolic/diastolic blood pressures were significantly higher than the non-fluctuators during the "OFF" state but not the "ON" state.
研究概览
详细说明
This is an observational study.
This study will only recruit Parkinson's subjects with rises in systolic blood pressure exceeding 50% of baseline during motor off periods to select for subjects with severe blood pressure fluctuations.
The clinical characteristics, including but not limited to, the degree of change of the motor tapping score, during an "off" period of this group of subjects with severe hypertension.
There is a screening visit, a at home monitoring period, and a one-time 4-8 hour study visit for subjects that satisfy the inclusion criteria.
The screening visit will assess Parkinson's motor state and review the inclusion/exclusion criteria.
The at home monitoring period will measure blood pressure twice a levodopa cycle for 5 cycles (for most subjects, this will be for two days and is dependent on the subject's clinical levodopa cycle).
Measurements will occur pre-levodopa dose (the maximal "OFF" time), and half-way through the cycle (maximal "ON" time).
The percentage of change will be calculated and those that have a systolic change of greater than or equal to 50% will proceed to the outpatient visit.
The outpatient visit will measure blood pressure, pulse, Parkinson's motor symptoms, and plasma levodopa levels.
研究类型
观察性的
注册 (预期的)
10
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Oregon
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Portland、Oregon、美国、97239
- VA Portland Health Care System
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 99年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Parkinson's disease participants with motor fluctuations.
描述
Inclusion Criteria:
- Idiopathic Parkinson's disease fulfilling UK Brain Bank clinical criteria.
- Treatment with chronic levodopa (levodopa treatment for ≥ 3 years).
- Rise in "OFF" systolic blood pressure exceeding 50% of baseline "ON" systolic blood pressure as shown by at home monitoring.
- History of "wearing off" prior to 4 hours after the previous levodopa dose per patient report or chart documentation.
Exclusion Criteria:
- Daily beta-blocker therapy.
- Diabetes mellitus, autonomic neuropathy, or other condition known to alter autonomic functions.
- Significant cognitive impairment as measured by the Montreal Cognitive Assessment score of < 16
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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 |
|---|---|
|
Fluctuator
Parkinson's subjects with rises in systolic blood pressure exceeding 50% of baseline during motor off periods to select for subjects with severe blood pressure fluctuations.
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Observational
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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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Systolic Blood Pressure Change
大体时间：Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.
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Blood pressure measurement taken at lowest "OFF" rating on the Unified Parkinson's Disease Rating Scale (UPDRS) and highest "ON" rating on the UPDRS.
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Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diastolic Blood Pressure Change
大体时间：Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.
|
Blood pressure measurement taken at lowest "OFF" rating on the Unified Parkinson's Disease Rating Scale (UPDRS) and highest "ON" rating on the UPDRS.
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Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Baratti M, Calzetti S. Fluctuation of arterial blood pressure during end-of-dose akinesia in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1984 Nov;47(11):1241-3. doi: 10.1136/jnnp.47.11.1241.
- Chase TN, Mouradian MM, Engber TM. Motor response complications and the function of striatal efferent systems. Neurology. 1993 Dec;43(12 Suppl 6):S23-7.
- Pursiainen V, Korpelainen JT, Haapaniemi TH, Sotaniemi KA, Myllyla VV. Blood pressure and heart rate in parkinsonian patients with and without wearing-off. Eur J Neurol. 2007 Apr;14(4):373-8. doi: 10.1111/j.1468-1331.2007.01672.x.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年2月6日
初级完成 (预期的)
2022年12月31日
研究完成 (预期的)
2022年12月31日
研究注册日期
首次提交
2018年1月8日
首先提交符合 QC 标准的
2018年2月8日
首次发布 (实际的)
2018年2月15日
研究记录更新
最后更新发布 (实际的)
2021年11月16日
上次提交的符合 QC 标准的更新
2021年11月15日
最后验证
2021年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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