Brain BOLD fMRI in Hypertensive and Normotensive Participants

NCT03473275 | Completed

• 1 other identifier: 2018-00105
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension,Essential

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in brain BOLD signal intensity

  Changes in the brain BOLD fMRI signal of the brainstem in response to a cold pressor test

  1.5 hours

Secondary Outcomes (3)

• Functional connectivity (resting state and effective connectivity)

  1.5 hours

• Structural connectivity

  30 minutes

• Correlation between brain BOLD fMRI and renal ultrasound

  2 hours

Study Arms (4)

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.

Diagnostic Test: Cold Pressor test; Diagnostic Test: PinPrick test

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.

Diagnostic Test: Cold Pressor test

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.

Diagnostic Test: Cold Pressor test

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.

Diagnostic Test: Cold Pressor test

Interventions

Cold Pressor test DIAGNOSTIC_TEST

Both feet in icy waterbath alternated with body temperature water

1: control; 2: untreated hypertensive; 3. resistant hypertensive; 4. renal denervation

PinPrick test DIAGNOSTIC_TEST

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

1: control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy normotensive participants: university employees mainly Hypertensive patients: from the outpatient clinic of the Nephrology Service Resistant hypertensive patients (renal denervated and non-denervated): from the outpatient clinic of the Nephrology Service

You may qualify if:

• signed informed consent
• capable of discernment

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (1)

CHUV, nephrology service

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma: cathecholamines, plasma renin activity (PRA), Aldosterone, Neuropeptide Y (NPY)

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gregoire Wuerzner, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator, MD

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 22, 2018
• Study Start: August 16, 2018
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Once data are published
• Access Criteria: available at zenodo :https://zenodo.org/

Locations

CH (1)