Clinical trial NCT04642586: Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI
Official title: Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI (SOUCHY) Brain Changes Due to Hypertension: a Multimodal MRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: MRI, Hypertension
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Presence of a cerebral zone with a z-score > 1.96
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: White matter hypersignals
timeFrame: through study completion, an average of 1 year
measure: Microbleeds
timeFrame: through study completion, an average of 1 year
measure: Gaps
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Correlation between MRI data and clinical scales
timeFrame: through study completion, an average of 1 year
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHU Toulouse
name: Jean Darcourt, MD
role: PRINCIPAL_INVESTIGATOR
References: