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Brain BOLD fMRI in Hypertensive and Normotensive Participants

Central Blood Pressure Regulation by the Brainstem and Influence by Renal Sympathetic Afference: a Functional Magnetic Resonance Imaging (MRI) Study in Hypertensive and Normotensive Participants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03473275
Acronym
BRAIrdN
Enrollment
84
Registered
2018-03-22
Start date
2018-08-16
Completion date
2022-08-12
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension,Essential

Keywords

Sympathetic nervous system, Blood oxygen level dependent, Brainstem, Contrast enhanced ultrasound, Kidney function, Hypertension, Renal denervation

Brief summary

This study will explore the brainstem activity in response to stress in hypertensive patients and normotensive subjects. In addition, it will evaluate if the response in hypertensive patients can be modulated by blocking the afferent signalling of sympathetic nervous system from the kidney to the brain achieved by renal denervation. The investigators hypothesize that the change in BOLD signal intensity in response to stress is higher in hypertensive patients than in normotensive subjects and that in patients responsive to renal denervation the change in BOLD signal intensity in response to stress is decreased compared to non-responders or to non-denervated resistant hypertensive patients.

Detailed description

In hypertension, the overactivity of the sympathetic nervous system (SNS) has been found to be implicated in its initiation, maintenance and adverse consequences. The SNS is composed of an afferent and efferent arm, which brings sensory information to the brain (e.g. brainstem and hypothalamus) and transmits sympathetic outflow from the brain to the peripheral organs, respectively. Selective removal of the afferent renal component of the SNS can modulate central sympathetic outflow to the kidney, heart and vasculature in animals. The specific contribution of afferent nerve signalling in hypertension and in the potential antihypertensive effect of renal denervation has not been studied in humans.

Interventions

DIAGNOSTIC_TESTCold Pressor test

Both feet in icy waterbath alternated with body temperature water

DIAGNOSTIC_TESTPinPrick test

Pricking both feet with a needle using gravity (without penetrating) alternated with cotton swap

Sponsors

Ecole Polytechnique Fédérale de Lausanne
CollaboratorOTHER
Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* signed informed consent * capable of discernment

Exclusion criteria

* having contra-indications for MRI (claustrophobia, cardiac pacemaker or other metallic or mechanical implant or device, etc.) * pregnant women * lower limb sensitive neuropathy * Blood pressure \>180/110 mmHg during washout period (for hypertensive patients) * Intolerance to Sonovue®(ultrasound contrast agent) * Acute or chronic disease other than hypertension that influences renal function * taking medication/drugs, except of calcium channel blockers for resistant hypertensive patients

Design outcomes

Primary

MeasureTime frameDescription
Change in brain BOLD signal intensity1.5 hoursChanges in the brain BOLD fMRI signal of the brainstem in response to a cold pressor test

Secondary

MeasureTime frameDescription
Functional connectivity (resting state and effective connectivity)1.5 hoursActivation patterns in spatially separated brain regions tending to have synchronous activity in resting state and activation pattern changes during a cold pressor test
Structural connectivity30 minutesMap of anatomical (neural) connections within the brain in normotensive subjects and hypertensive patients
Correlation between brain BOLD fMRI and renal ultrasound2 hoursCorrelation between changes in brain BOLD signal and renal (contrast-enhanced) ultrasound endpoints

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026