Hypertension,EssentialBRAIrdNNCT03473275
Brain BOLD fMRI in Hypertensive and Normotensive Participants
An observational study of Hypertension,Essential, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- Cold Pressor test and PinPrick test
- How many people
- 84 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Aug 2018to 12 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- signed informed consent
- capable of discernment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Hypertension,Essential
- Being tested
- Cold Pressor test, PinPrick test
- Keywords
- Sympathetic nervous system, Blood oxygen level dependent, Brainstem, Contrast enhanced ultrasound, Kidney function, Hypertension, Renal denervation
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Pressor testDiagnostic test
Both feet in icy waterbath alternated with body temperature water
PinPrick testDiagnostic test
Pricking both feet with a needle using gravity (without penetrating) alternated with cotton swap
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Cold Pressor test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain BOLD signal intensity
Changes in the brain BOLD fMRI signal of the brainstem in response to a cold pressor test
Measured: 1.5 hours
Secondary outcomes (3)
Functional connectivity (resting state and effective connectivity)
Activation patterns in spatially separated brain regions tending to have synchronous activity in resting state and activation pattern changes during a cold pressor test
Measured: 1.5 hours
Structural connectivity
Map of anatomical (neural) connections within the brain in normotensive subjects and hypertensive patients
Measured: 30 minutes
Correlation between brain BOLD fMRI and renal ultrasound
Correlation between changes in brain BOLD signal and renal (contrast-enhanced) ultrasound endpoints
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start16 Aug 2018
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Responsible party
- Principal investigator, PD Dr. Grégoire Wuerzner, Centre Hospitalier Universitaire Vaudois
- Investigators
- Gregoire Wuerzner, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473275
- Sponsor's protocol ID
- 2018-00105
- Other IDs
- 2018
- Acronym
- BRAIrdN
- Status last verified
- Feb 2023
- First submitted
- 15 Mar 2018
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data of participants that have signed the consent allowing their anonymized data to be shared, will be made available via the repository Zenodo
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03473275
- Acronym / sponsor ID
- BRAIrdN / 2018-00105
- Conditions
- Hypertension,Essential
- Keywords
- Sympathetic nervous system, Blood oxygen level dependent, Brainstem, Contrast enhanced ultrasound, Kidney function, Hypertension, Renal denervation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: control | – | Diagnostic Test: Cold Pressor test, Diagnostic Test: PinPrick testHealthy 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. |
| 2: untreated hypertensive | – | Diagnostic Test: Cold Pressor testUntreated (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. |
| 3. resistant hypertensive | – | Diagnostic Test: Cold Pressor testPatients 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. |
| 4. renal denervation | – | Diagnostic Test: Cold Pressor testPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- signed informed consent
- capable of discernment
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Pressor testBoth feet in icy waterbath alternated with body temperature water | Diagnostic test | 1: control, 2: untreated hypertensive, 3. resistant hypertensive, 4. renal denervation |
| PinPrick testPricking both feet with a needle using gravity (without penetrating) alternated with cotton swap | Diagnostic test | 1: control |
Primary outcome
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
3 secondary outcomes
Functional connectivity (resting state and effective connectivity)
Time frame: 1.5 hours
Structural connectivity
Time frame: 30 minutes
Correlation between brain BOLD fMRI and renal ultrasound
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Yes. Anonymized data of participants that have signed the consent allowing their anonymized data to be shared, will be made available via the repository Zenodo
Related trials for Hypertension,Essential
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregoire Wuerzner, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension,Essential, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain BOLD signal intensity (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.