Parkinson DiseaseCLIN-HTN-PDNCT03433950
Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs.
An observational study of Parkinson Disease and Hypertension, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson Disease, Hypertension, Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease participants with motor fluctuations.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Hypertension, Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use
- Being tested
- No Intervention
- Keywords
- antiparkinson
- Medical subject headings
- Parkinson Disease, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.
Secondary outcomes (1)
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.
Measured: Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start6 Feb 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: COVID-19 Research Restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Anne Chung, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433950
- Sponsor's protocol ID
- 17490
- Other IDs
- VA IRB 4143
- Acronym
- CLIN-HTN-PD
- Status last verified
- Nov 2021
- First submitted
- 8 Jan 2018
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 6502182Chase TN, Mouradian MM, Engber TM. Motor response complications and the function of striatal efferent systems. Neurology. 1993 Dec;43(12 Suppl 6):S23-7.
PubMed 8264907Pursiainen 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.
PubMed 17388983
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs.
- ClinicalTrials.gov ID
- NCT03433950
- Acronym / sponsor ID
- CLIN-HTN-PD / 17490
- Conditions
- Parkinson Disease, Hypertension, Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use
- Keywords
- antiparkinson
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID-19 Research Restrictions
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluctuator | – | Other: No InterventionParkinson'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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease participants with motor fluctuations.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionObservational | Other | Fluctuator |
Primary outcome
Systolic Blood Pressure Change
Time frame: 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.
1 secondary outcome
Diastolic Blood Pressure Change
Time frame: Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Results publication: PubMed 6502182Baratti 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.
- Results publication: PubMed 8264907Chase TN, Mouradian MM, Engber TM. Motor response complications and the function of striatal efferent systems. Neurology. 1993 Dec;43(12 Suppl 6):S23-7.
- Results publication: PubMed 17388983Pursiainen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Hypertension, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure Change (time frame: Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433950, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.