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
| Registry | NCT07139756, acronym HYPOPARK |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 130 (Estimated) |
| Sponsor | Centre Hospitalier Universitaire Vaudois (Other); collaborators: Ecole Polytechnique Fédérale de Lausanne, University Hospital, Geneva |
| Conditions | Parkinson Disease, Orthostatic Hypotension |
| Interventions | Lower body negative pressure (Diagnostic test) |
| Dates | start 2025-10-01 (estimated), primary completion 2027-09-30 (estimated), completion 2028-03-31 (estimated), first posted 2025-08-24, last updated 2025-08-24 |
| Locations | 1 site in Switzerland |
Related Papers Related Patents Related Grants Related Experts
All trials for Parkinson Disease All trials for Orthostatic Hypotension All trials of Lower body negative pressure
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
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Healthy volunteers | Diagnostic Test: Lower body negative pressure | Healthy 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 pressure | 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 | |
| Parkinson patients with orthostatic hypotension | Diagnostic Test: Lower body negative pressure | 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 |
Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers
Phase 1: Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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: Inclusion Criteria: * Signed informed consent * Fulfilling Movement Disorder Society clinical criteria for "clinically established PD" * 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 Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Lausanne, Canton of Vaud | Switzerland |