Brain BOLD fMRI in Hypertensive and Normotensive Participants

NCT ID: NCT03473275

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-16

Study Completion Date

2022-08-12

Brief Summary

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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

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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.

Conditions

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Hypertension,Essential

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1: control

Healthy normotensive participants. Cold pressor test on feet 3 times for 40 seconds during brain BOLD fMRI (2 runs), renal ultrasound and contrast-enhanced ultrasound.

PinPrick test on feet 3 times for 40 seconds during brain BOLD fMRI (2 runs), renal ultrasound and contrast-enhanced ultrasound.

Cold Pressor test

Intervention Type DIAGNOSTIC_TEST

Both feet in icy waterbath alternated with body temperature water

PinPrick test

Intervention Type DIAGNOSTIC_TEST

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

2: untreated hypertensive

Untreated (or off antihypertensive drugs) hypertensive patients (ABPM proven essential hypertension).

Cold pressor test on feet 3 times for 40 seconds during BOLD fMRI (2 runs), renal ultrasound and contrast-enhanced ultrasound.

Cold Pressor test

Intervention Type DIAGNOSTIC_TEST

Both feet in icy waterbath alternated with body temperature water

3. resistant hypertensive

Patients with proven resistant hypertension and not renal denervated or for whom a renal denervation is planned according to the criteria of the CHUV.

Cold pressor test on feet 3 times for 40 seconds during BOLD fMRI (2 runs), renal ultrasound and contrast-enhanced ultrasound.

Cold Pressor test

Intervention Type DIAGNOSTIC_TEST

Both feet in icy waterbath alternated with body temperature water

4. renal denervation

Patients with a renal denervation. Cold pressor test on feet 3 times for 40 seconds during BOLD fMRI (2 runs), renal ultrasound and contrast-enhanced ultrasound.

Cold Pressor test

Intervention Type DIAGNOSTIC_TEST

Both feet in icy waterbath alternated with body temperature water

Interventions

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Cold Pressor test

Both feet in icy waterbath alternated with body temperature water

Intervention Type DIAGNOSTIC_TEST

PinPrick test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Grégoire Wuerzner

Primary Investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregoire Wuerzner, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

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CHUV, nephrology service

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2018-00105

Identifier Type: -

Identifier Source: org_study_id

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