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NCT07139756

Deciphering the Mechanisms of Central BP Regulation in Patients With PD Associated With Orthostatic Hypotension

Sponsor: Centre Hospitalier Universitaire Vaudois

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

130

Start Date

2025-10-01

Completion Date

2028-03-31

Last Updated

2025-08-24

Healthy Volunteers

Yes

Conditions

Parkinson Disease Orthostatic Hypotension

Interventions

DIAGNOSTIC_TEST

Lower body negative pressure

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

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

Locations (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland