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Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs.

NCT ID: NCT03433950

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-06

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Hypertension Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use

Keywords

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antiparkinson

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type OTHER

Observational

Interventions

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No Intervention

Observational

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Kathryn Anne Chung

Prinicpal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VA Portland Health Care System

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 6502182 (View on PubMed)

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.

Reference Type RESULT
PMID: 8264907 (View on PubMed)

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.

Reference Type RESULT
PMID: 17388983 (View on PubMed)

Other Identifiers

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VA IRB 4143

Identifier Type: OTHER

Identifier Source: secondary_id

17490

Identifier Type: -

Identifier Source: org_study_id