Parkinson DiseaseHYPOPARKNCT07139756
Deciphering the Mechanisms of Central BP Regulation in Patients With PD Associated With Orthostatic Hypotension
An observational study of Parkinson Disease and Orthostatic Hypotension, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Phase 1 objective: test the feasibility of using a 3Tesla MRI scanner instead of a 7Tesla MRI scanner to measure brainstem responses to LBNP in healthy participants. Phase 2 primary objective: compare the brainstem responses to LBNP in patients with PD associated with OH to PD patients without OH using BOLD fMRI Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Orthostatic Hypotension
- What is being tested?
- Lower body negative pressure
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2025to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Phase 1: population of healthy participants Phase 2: population of PD patients with or without OH
Who may be able to join
- Signed informed consent
- Age ≥ 18 years and <75 years
- Normal office blood pressure (<140/90 mmHg)
- For women of childbearing potential: using or willing to use during the study a reliable contraception method compatible with MRI
- Signed informed consent
- Fulfilling Movement Disorder Society clinical criteria for "clinically established PD"
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- Age ≥18 years and <75 years
- PD treated by dopamine replacement therapy (DRT)
- Willing and able to comply with the visit schedule and study procedures
- Autonomous in daily life
- Schellong test showing OH (drop of Systolic BP >20 mmHg or Diastolic BP >10 mmHg)(for study group with OH) or no OH (for studygroup without OH)
- For women of childbearing potential: using or willing to use during the study a reliable contraception method compatible with MRI
Who cannot join
- Schellong test showing OH (drop of Systolic BP >20 mmHg or Diastolic BP >10 mmHg)
- Pregnant or lactating women
- Refusal to be informed of incidental findings
- Any medication (acute or chronic prescription) except oral contraception
- Clinical significant abnormal blood test as assessed by the investigator
- Chronic or acute illness
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- Concomitant participation in a clinical trial
- Blood donation in the 60 previous days
- Contra-indications for MRI
- Unable to follow study procedures
- Having a hierarchical relationship with the investigator or being family of the investigator
- Phase 2:
- Unable to give an informed consent
- BP > 180/110 mmHg on 24-hour ambulatory blood pressure monitoring
- eGFR < 45 ml/min/1.73 ml/min/m2 by CKD-EPI equation
- having contra-indications for MRI
- Pregnant or lactating women
- Refusal to be informed of incidental findings
- Allergy to components of contrast agent Sonovue®
- Living in an institution
- Dementia
- Type 2 diabetes
- Stroke or myocardial infarction in the past 6 months
- Blood donation in the previous 6 months
- Active oncology treatment
- Having a hierarchical relationship with the investigator or being family of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Deciphering the Mechanisms of Central Blood Pressure Regulation in Patients With Parkinson Disease Associated With Orthostatic Hypotension: A 2-phase Observational Study With Healthy Participants and Patients With Parkinson's Disease
Phase 1 objective: test the feasibility of using a 3Tesla MRI scanner instead of a 7Tesla MRI scanner to measure brainstem responses to LBNP in healthy participants.
Phase 2 primary objective: compare the brainstem responses to LBNP in patients with PD associated with OH to PD patients without OH using BOLD fMRI
Read the detailed description
Phase 1 objective: test the feasibility of using a 3Tesla MRI scanner instead of a 7Tesla MRI scanner to measure brainstem responses to LBNP in healthy participants using BOLD fMRI
Phase 2 primary objective: compare the brainstem responses to LBNP in patients with PD associated with OH to PD patients without OH using BOLD fMRI
Phase 2 secondary objectives:
- assess modulation of functional connectivity in response to LBNP (effective connectivity analysis by psycho-physiological interactions (PPI)) and determine differences between the two groups
- assess functional connectivity in resting state and determine differences between the two groups
- compare structural connectivity in both groups using tractography
- compare renal response to LBNP in both groups using contrast-enhanced ultrasound
- compare pre-cerebral flow response to LBNP in both groups
- Conditions
- Parkinson Disease, Orthostatic Hypotension
- Being tested
- Lower body negative pressure
- Keywords
- lower body negative pressure, parkinson disease, orthostatic hypotension
- Medical subject headings
- Parkinson Disease, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower body negative pressureDiagnostic test
LBNP is a technique that redistributes blood from the upper body to the dependent regions of the legs, thus reducing central venous pressure and venous return and thereby activating the sympathetic nervous system (SNS). The subject is placed in a cylindrical airtight tank, which is sealed at the level of the iliac crests, and sub-atmospheric pressure is produced using a vacuum pump. It can be used to characterize the cardiovascular responses to orthostatic stress
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers with normal office blood pressure (<140/90 mmHg).
Lower body negative pressure during brain BOLD fMRI in 3T and 7T MRI scanner. Receives: Diagnostic Test: Lower body negative pressure | |
| Parkinson patients without orthostatic hypotension | Patients with clinically established Parkinson disease, treated by dopamine replacement therapy, and without orthostatic hypotension as shown by a Schellong test.
Lower body negative pressure during brain BOLD fMRI, renal contrast-enhanced ultrasound Receives: Diagnostic Test: Lower body negative pressure | |
| Parkinson patients with orthostatic hypotension | Patients with clinically established Parkinson disease, treated by dopamine replacement therapy, and having orthostatic hypotension as shown by a Schellong test.
Lower body negative pressure during brain BOLD fMRI, renal contrast-enhanced ultrasound Receives: Diagnostic Test: Lower body negative pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences and changes in BOLD fMRI signal intensity
Changes in brain BOLD fMRI signal in the dorsolateral medulla of the brainstem in response to LBNP
Measured: 1.5 hour
Secondary outcomes (4)
Functional connectivity
Activation patterns in spatially separated brain regions tending to have synchronous activity in resting state and activation pattern change during LBNP
Measured: 1.5 hour
Structural connectivity
Map of anatomical (neural) connections within the brain in PD patients with and without OH
Measured: 30 minutes
Contrast-enhanced renal ultrasound
Changes in renal perfusion in response to LBNP
Measured: 1.5 hour
pre-cerebral blood flow
changes in pre-cerebral blood flow in response to LBNP
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne, University Hospital, Geneva
- Responsible party
- Principal investigator, Gregoire Wuerzner; MD, Centre Hospitalier Universitaire Vaudois
- Investigators
- Grégoire Wuerzner, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139756
- Sponsor's protocol ID
- 2024-01828
- Acronym
- HYPOPARK
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Mechanisms of Central Blood Pressure Regulation in Patients With Parkinson Disease Associated With Orthostatic Hypotension: A 2-phase Observational Study With Healthy Participants and Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07139756
- Acronym / sponsor ID
- HYPOPARK / 2024-01828
- Conditions
- Parkinson Disease, Orthostatic Hypotension
- Keywords
- lower body negative pressure, parkinson disease, orthostatic hypotension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne, University Hospital, Geneva
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Aug 2025 (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.
Phase 1 objective: test the feasibility of using a 3Tesla MRI scanner instead of a 7Tesla MRI scanner to measure brainstem responses to LBNP in healthy participants.
Phase 2 primary objective: compare the brainstem responses to LBNP in patients with PD associated with OH to PD patients without OH using BOLD fMRI
Detailed description
Phase 1 objective: test the feasibility of using a 3Tesla MRI scanner instead of a 7Tesla MRI scanner to measure brainstem responses to LBNP in healthy participants using BOLD fMRI
Phase 2 primary objective: compare the brainstem responses to LBNP in patients with PD associated with OH to PD patients without OH using BOLD fMRI
Phase 2 secondary objectives:
- assess modulation of functional connectivity in response to LBNP (effective connectivity analysis by psycho-physiological interactions (PPI)) and determine differences between the two groups
- assess functional connectivity in resting state and determine differences between the two groups
- compare structural connectivity in both groups using tractography
- compare renal response to LBNP in both groups using contrast-enhanced ultrasound
- compare pre-cerebral flow response to LBNP in both groups
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Diagnostic Test: Lower body negative pressureHealthy volunteers with normal office blood pressure (<140/90 mmHg). Lower body negative pressure during brain BOLD fMRI in 3T and 7T MRI scanner. |
| Parkinson patients without orthostatic hypotension | – | Diagnostic Test: Lower body negative pressurePatients with clinically established Parkinson disease, treated by dopamine replacement therapy, and without orthostatic hypotension as shown by a Schellong test. Lower body negative pressure during brain BOLD fMRI, renal contrast-enhanced ultrasound |
| Parkinson patients with orthostatic hypotension | – | Diagnostic Test: Lower body negative pressurePatients with clinically established Parkinson disease, treated by dopamine replacement therapy, and having orthostatic hypotension as shown by a Schellong test. Lower body negative pressure during brain BOLD fMRI, renal contrast-enhanced ultrasound |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Phase 1: population of healthy participants Phase 2: population of PD patients with or without OH
Key inclusion criteria (12 listed)
- Signed informed consent
- Age ≥ 18 years and <75 years
- Normal office blood pressure (<140/90 mmHg)
- For women of childbearing potential: using or willing to use during the study a reliable contraception method compatible with MRI
- Signed informed consent
Key exclusion criteria (26 listed)
- Schellong test showing OH (drop of Systolic BP >20 mmHg or Diastolic BP >10 mmHg)
- Pregnant or lactating women
- Refusal to be informed of incidental findings
- Any medication (acute or chronic prescription) except oral contraception
- Clinical significant abnormal blood test as assessed by the investigator
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 |
|---|---|---|
| Lower body negative pressureLBNP is a technique that redistributes blood from the upper body to the dependent regions of the legs, thus reducing central venous pressure and venous return and thereby activating the sympathetic nervous system (SNS). The subject is placed in a cylindrical airtight tank, which is sealed at the level of the iliac crests, and sub-atmospheric pressure is produced using a vacuum pump. It can be used to characterize the cardiovascular responses to orthostatic stress | Diagnostic test | Healthy volunteers, Parkinson patients with orthostatic hypotension, Parkinson patients without orthostatic hypotension |
Primary outcome
Differences and changes in BOLD fMRI signal intensity
Time frame: 1.5 hour
Changes in brain BOLD fMRI signal in the dorsolateral medulla of the brainstem in response to LBNP
4 secondary outcomes
Functional connectivity
Time frame: 1.5 hour
Structural connectivity
Time frame: 30 minutes
Contrast-enhanced renal ultrasound
Time frame: 1.5 hour
pre-cerebral blood flow
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
Grégoire Wuerzner principal investigator
CHUV
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 Orthostatic Hypotension, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 12 inclusion and 26 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: opening soon, as of the sponsor's last update on 24 Aug 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grégoire Wuerzner, Prof (+41 79 556 1973, Gregoire.Wuerzner@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences and changes in BOLD fMRI signal intensity (time frame: 1.5 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.