Detection of Subclinical Cerebral Suffering Related to Hypertension Using Multimodal MRI

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Diagnostic Test: multimodal magnetic resonance imaging; Diagnostic Test: blood test; Diagnostic Test: neuropsychological assessment

• Registration Number: NCT04642586
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-24
• Study Start: 2021-01-07
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14
• Primary Completion: 2023-12-05
• Study Completion: 2024-01-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertensive participants	multimodal magnetic resonance imaging	diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure;
Normotensive participants	neuropsychological assessment	absence of HTA confirmed by Ambulatory Blood Pressure Measure
Hypertensive participants	blood test	diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure;
Normotensive participants	multimodal magnetic resonance imaging	absence of HTA confirmed by Ambulatory Blood Pressure Measure
Hypertensive participants	neuropsychological assessment	diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure;
Normotensive participants	blood test	absence of HTA confirmed by Ambulatory Blood Pressure Measure

Primary Outcome Measures

Name	Time	Method
Presence of a cerebral zone with a z-score > 1.96	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).

Secondary Outcome Measures

Name	Time	Method
White matter hypersignals	through study completion, an average of 1 year	FAZEKAS score estimating T2 hypersignals of the white matter,
Microbleeds	through study completion, an average of 1 year	number and location of microbleeds,
Gaps	through study completion, an average of 1 year	number of gaps

Trial Locations

Locations (1)

CHU de Toulouse; 🇫🇷 Toulouse, France