NCT04642586

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 7, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

November 6, 2020

Last Update Submit

March 13, 2023

Conditions

Hypertension

Keywords

MRI, Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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).

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • White matter hypersignals

    through study completion, an average of 1 year

  • Microbleeds

    through study completion, an average of 1 year

  • Gaps

    through study completion, an average of 1 year

Other Outcomes (1)

  • Correlation between MRI data and clinical scales

    through study completion, an average of 1 year

Study Arms (2)

Hypertensive participants

EXPERIMENTAL

diagnosed HTA within 5 years, treated or confirmed by Ambulatory Blood Pressure Measure;

Diagnostic Test: multimodal magnetic resonance imagingDiagnostic Test: blood testDiagnostic Test: neuropsychological assessment

Normotensive participants

EXPERIMENTAL

absence of HTA confirmed by Ambulatory Blood Pressure Measure

Diagnostic Test: multimodal magnetic resonance imagingDiagnostic Test: blood testDiagnostic Test: neuropsychological assessment

Interventions

multimodal magnetic resonance imagingDIAGNOSTIC_TEST

Brain MRI exam (without contrast injection)

Also known as: MRI
Hypertensive participantsNormotensive participants
blood testDIAGNOSTIC_TEST

Blood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), .

Hypertensive participantsNormotensive participants
neuropsychological assessmentDIAGNOSTIC_TEST

neuropsychological assessment

Hypertensive participantsNormotensive participants

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Jean Darcourt, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Darcourt, MD

CONTACT

+33561775620darcourt.j@chu-toulouse.fr

Patrice Péran, PHD

CONTACT

05 62 74 61 96patrice.peran@inserm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 24, 2020

Study Start

January 7, 2021

Primary Completion

December 5, 2023

Study Completion

January 5, 2024

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)