Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs. (CLIN-HTN-PD)

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.

Study Overview

• Status: Suspended
• Conditions: Hypertension; Parkinson Disease; Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Other: No Intervention

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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • VA Portland Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease participants with motor fluctuations.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No Intervention; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure Change	Blood pressure measurement taken at lowest "OFF" rating on the Unified Parkinson's Disease Rating Scale (UPDRS) and highest "ON" rating on the UPDRS.	Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure Change	Blood pressure measurement taken at lowest "OFF" rating on the Unified Parkinson's Disease Rating Scale (UPDRS) and highest "ON" rating on the UPDRS.	Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: antiparkinson
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Hypertension; Parkinson Disease
• Other Study ID Numbers: 17490; VA IRB 4143 (Other Identifier: VA Portland Health System)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No