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

Hypertension Clinical Trial

— CLIN-HTN-PD  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03433950
• Other study ID #: 17490
• Secondary ID: VA IRB 4143
• Status: Suspended
• Start date: February 6, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use
• Hypertension
• Parkinson Disease

Intervention

Other:
• No Intervention
Observational

Locations

Country	Name	City	State
United States	VA Portland Health Care System	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

Pursiainen V, Korpelainen JT, Haapaniemi TH, Sotaniemi KA, Myllylä VV. Blood pressure and heart rate in parkinsonian patients with and without wearing-off. Eur J Neurol. 2007 Apr;14(4):373-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.