Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs.
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Parkinsons Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/3/2019 |
| Start Date: | February 6, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Brenna M Lobb, MS, MPH |
| Email: | lobbb@ohsu.edu |
| Phone: | 5032208262 |
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.
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.
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.
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.
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
We found this trial at
1
site
Portland, Oregon 97239
Principal Investigator: Kathryn Chung, MD
Phone: 503-220-8262
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