Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-02-21 @ 8:41 PM
Study NCT ID:
NCT03433950
Status:
SUSPENDED
Last Update Posted:
2021-11-16
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs.
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs.
Status:
SUSPENDED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19 Research Restrictions
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLIN-HTN-PD
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| VA IRB 4143 | OTHER | VA Portland Health System | View |