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

Suspended

• Conditions: Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use; Parkinson Disease; Hypertension
• Interventions: Other: No Intervention

• Registration Number: NCT03433950
• Lead Sponsor: Oregon Health and Science University

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 Timeline

• Study First Submitted: 2018-01-08
• Study Start: 2018-02-06
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fluctuator	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure Change	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.

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure Change	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.

Trial Locations

Locations (1)

VA Portland Health Care System; 🇺🇸 Portland, Oregon, United States