NCT03433950

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

4.9 years

First QC Date

January 8, 2018

Last Update Submit

November 15, 2021

Conditions

Parkinson DiseaseHypertensionAntiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use

Keywords

antiparkinson

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Diastolic Blood Pressure Change

    Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.

Study Arms (1)

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

Interventions

No InterventionOTHER

Observational

Fluctuator

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson's disease participants with motor fluctuations.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Related 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. doi: 10.1136/jnnp.47.11.1241.

    PMID: 6502182RESULT

  • 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.

    PMID: 8264907RESULT

  • 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.

    PMID: 17388983RESULT

MeSH Terms

Conditions

Parkinson DiseaseHypertension

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator

Study Record Dates

First Submitted

January 8, 2018

First Posted

February 15, 2018

Study Start

February 6, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 16, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)