HypertensionSOUCHYNCT04642586
Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI
A study testing multimodal magnetic resonance imaging, blood test and neuropsychological assessment in people with Hypertension, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Investigators propose here to study the brain consequences of hypertension in patients without cognitive complaints and neurological signs. The evaluation of brain suffering requires considering various possible brain damage. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- multimodal magnetic resonance imaging, blood test and neuropsychological assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2021to 5 Jan 2024
- Phase
- Interventional
- 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female 35 to 50 y.o.;for patients: diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure;
- For normotensive participants:Absence of HTA confirmed by Ambulatory Blood Pressure Measure
Who cannot join
- Known neurological history, stroke, symptomatic headache, long-term use of neuroleptic, tricyclic, MAOI, anti-serotonergic antidepressant medications, diabetes mellitus, treated dyslipidemia, body mass index greater than 30 kg / m, participants who smoked or smoked more than 10 packs-year, MRI contraindication ;
- For HTA patients only: Renal artery dysplasia responsible for hypertension, clinical Cushing Syndrome.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Toulouse
Toulouse, 31000
Jean Darcourt, MD
About this study
Official title: Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI (SOUCHY) Brain Changes Due to Hypertension: a Multimodal MRI
Investigators propose here to study the brain consequences of hypertension in patients without cognitive complaints and neurological signs. The evaluation of brain suffering requires considering various possible brain damage. The team developed a multimodal MRI approach capable of detecting and quantifying numerous indices (e.g. morphometric, microstructural) to evaluate possible brain suffering. This project aims to identify individually signs of cerebral suffering in hypertensive patients compared to a population of normotensive volunteers, using advanced multiparametric MRI methods.
Read the detailed description
Hypertension is a risk factor for many brain pathologies, such as ischemic and hemorrhagic neurodegenerative diseases or stroke. The literature seems to agree on the relationship between hypertension and brain damage, and on the benefit of the management of hypertension to prevent certain neurological pathologies. However, to our knowledge, no single study has shown signs of subclinical brain damage in patients with hypertension. At present, no brain MRI is recommended in these patients. In the present study, hypertensive and normotensive patients will undergo a neurological exam, a neuropsychological exam, a biological exam and a MRI exam to individually identify signs of cerebral suffering.
- Conditions
- Hypertension
- Being tested
- multimodal magnetic resonance imaging, blood test, neuropsychological assessment
- Keywords
- MRI, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal magnetic resonance imagingDiagnostic test
Also called MRI
Brain MRI exam (without contrast injection)
blood testDiagnostic test
Blood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), .
neuropsychological assessmentDiagnostic test
neuropsychological assessment
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive participants | Experimental | diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure; Receives: Diagnostic Test: multimodal magnetic resonance imaging; Diagnostic Test: blood test; Diagnostic Test: neuropsychological assessment |
| Normotensive participants | Experimental | absence of HTA confirmed by Ambulatory Blood Pressure Measure Receives: Diagnostic Test: multimodal magnetic resonance imaging; Diagnostic Test: blood test; Diagnostic Test: neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a cerebral zone with a z-score > 1.96
the proportion of hypertensive patients who have at least one sign of cerebral suffering compared to the control group will be determined. For each MRI parameter, after coregistration, z score maps will be calculated for each hypertensive patient (individual vs normotensive group). The notion of cerebral suffering sign will be defined by the presence of a cerebral zone with a z-score greater than 1.96 (corresponding to a threshold of significance p <.05).
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
White matter hypersignals
FAZEKAS score estimating T2 hypersignals of the white matter,
Measured: through study completion, an average of 1 year
Microbleeds
number and location of microbleeds,
Measured: through study completion, an average of 1 year
Gaps
number of gaps
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start7 Jan 2021
- Primary completion5 Dec 2023 (estimated)
- Study completion5 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Darcourt, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642586
- Sponsor's protocol ID
- RC31/19/0055
- Acronym
- SOUCHY
- Status last verified
- Mar 2023
- First submitted
- 6 Nov 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI (SOUCHY) Brain Changes Due to Hypertension: a Multimodal MRI
- ClinicalTrials.gov ID
- NCT04642586
- Acronym / sponsor ID
- SOUCHY / RC31/19/0055
- Conditions
- Hypertension
- Keywords
- MRI, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 5 Dec 2023 (estimated)
- Study completion
- 5 Jan 2024 (estimated)
- First posted
- 24 Nov 2020 (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.
Investigators propose here to study the brain consequences of hypertension in patients without cognitive complaints and neurological signs. The evaluation of brain suffering requires considering various possible brain damage. The team developed a multimodal MRI approach capable of detecting and quantifying numerous indices (e.g. morphometric, microstructural) to evaluate possible brain suffering. This project aims to identify individually signs of cerebral suffering in hypertensive patients compared to a population of normotensive volunteers, using advanced multiparametric MRI methods.
Detailed description
Hypertension is a risk factor for many brain pathologies, such as ischemic and hemorrhagic neurodegenerative diseases or stroke. The literature seems to agree on the relationship between hypertension and brain damage, and on the benefit of the management of hypertension to prevent certain neurological pathologies. However, to our knowledge, no single study has shown signs of subclinical brain damage in patients with hypertension. At present, no brain MRI is recommended in these patients. In the present study, hypertensive and normotensive patients will undergo a neurological exam, a neuropsychological exam, a biological exam and a MRI exam to individually identify signs of cerebral suffering.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertensive participants | Experimental | Diagnostic Test: multimodal magnetic resonance imaging, Diagnostic Test: blood test, Diagnostic Test: neuropsychological assessmentdiagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure; |
| Normotensive participants | Experimental | Diagnostic Test: multimodal magnetic resonance imaging, Diagnostic Test: blood test, Diagnostic Test: neuropsychological assessmentabsence of HTA confirmed by Ambulatory Blood Pressure Measure |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female 35 to 50 y.o.;for patients: diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure;
- For normotensive participants:Absence of HTA confirmed by Ambulatory Blood Pressure Measure
Key exclusion criteria (2 listed)
- Known neurological history, stroke, symptomatic headache, long-term use of neuroleptic, tricyclic, MAOI, anti-serotonergic antidepressant medications, diabetes mellitus, treated dyslipidemia, body mass index greater than 30 kg / m, participants who smoked or smoked more than 10 packs-year, MRI contraindication ;
- For HTA patients only: Renal artery dysplasia responsible for hypertension, clinical Cushing Syndrome.
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 |
|---|---|---|
| multimodal magnetic resonance imagingAlso: MRIBrain MRI exam (without contrast injection) | Diagnostic test | Hypertensive participants, Normotensive participants |
| blood testBlood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), . | Diagnostic test | Hypertensive participants, Normotensive participants |
| neuropsychological assessmentneuropsychological assessment | Diagnostic test | Hypertensive participants, Normotensive participants |
Primary outcome
Presence of a cerebral zone with a z-score > 1.96
Time frame: through study completion, an average of 1 year
the proportion of hypertensive patients who have at least one sign of cerebral suffering compared to the control group will be determined. For each MRI parameter, after coregistration, z score maps will be calculated for each hypertensive patient (individual vs normotensive group). The notion of cerebral suffering sign will be defined by the presence of a cerebral zone with a z-score greater than 1.96 (corresponding to a threshold of significance p <.05).
3 secondary outcomes
White matter hypersignals
Time frame: through study completion, an average of 1 year
Microbleeds
Time frame: through study completion, an average of 1 year
Gaps
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Jean Darcourt, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal magnetic resonance imaging, blood test and neuropsychological assessment in people with Hypertension, run by University Hospital, Toulouse at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Mar 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Darcourt, MD (+33561775620 ext. 33, darcourt.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a cerebral zone with a z-score > 1.96 (time frame: through study completion, an average of 1 year). 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 14 Mar 2023.