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Completed

NCT Number: NCT03473275

Brain BOLD fMRI in Hypertensive and Normotensive Participants

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.

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Key information

Conditions

Hypertension,Essential Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHUV, nephrology service

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold Pressor test

Diagnostic Test

Both feet in icy waterbath alternated with body temperature water

PinPrick test

Diagnostic Test

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

Primary outcomes

  1. Change in brain BOLD signal intensity

    Time frame: 1.5 hours

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

Secondary outcomes

  1. Functional connectivity (resting state and effective connectivity)

    Time frame: 1.5 hours

    Activation patterns in spatially separated brain regions tending to have synchronous activity in resting state and activation pattern changes during a cold pressor test

  2. Structural connectivity

    Time frame: 30 minutes

    Map of anatomical (neural) connections within the brain in normotensive subjects and hypertensive patients

  3. Correlation between brain BOLD fMRI and renal ultrasound

    Time frame: 2 hours

    Correlation between changes in brain BOLD signal and renal (contrast-enhanced) ultrasound endpoints

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

  • Ecole Polytechnique Fédérale de Lausanne

Registry information

Official study title

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

Acronym: BRAIrdN

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2018
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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