Brain BOLD fMRI in Hypertensive and Normotensive Participants
NCT ID: NCT03473275
Last Updated: 2023-02-21
Study Results
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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COMPLETED
84 participants
OBSERVATIONAL
2018-08-16
2022-08-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
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
Both feet in icy waterbath alternated with body temperature water
PinPrick 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
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
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
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
PinPrick test
Pricking both feet with a needle using gravity (without penetrating) alternated with cotton swap
Eligibility Criteria
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Inclusion Criteria
* capable of discernment
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Ecole Polytechnique Fédérale de Lausanne
OTHER
Centre Hospitalier Universitaire Vaudois
OTHER
Responsible Party
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PD Dr. Grégoire Wuerzner
Primary Investigator, MD
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
Countries
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Other Identifiers
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2018-00105
Identifier Type: -
Identifier Source: org_study_id
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