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

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Conditions studied: Parkinson Disease, Hypertension, Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use

In brief

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.

Key facts

Study ID

NCT03433950

Run by

Oregon Health and Science University

People needed

10

Starts

2018-02-06

Expected to finish

2022-12-31

Last updated by the study team

2021-11-16

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• VA Portland Health Care System — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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