Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients

• Conditions: Hypertension
• Interventions: Other: No interventions

• Registration Number: NCT03986957
• Lead Sponsor: Neuromed IRCCS

Brief Summary

Hypertension is the major risk factor for vascular cognitive impairment (VCI). One of the main limitations in the clinical approach to VCI is that, by the time that it is manifested, it might be too late to reverse the neurodegenerative process. Thus, early identification of predictive signs of later dementia is demanding for management of hypertensive patients (HT).This aim claims for new methods that compute in a cloud all possible data sources coming from patients (brain imaging, cognitive profile, clinical data), to extract discriminative aggregate biomarkers. Thus, this study aims at: 1) characterizing the predictive potential of an aggregate biomarker for dementia in HT, based on brain imaging, clinical and cognitive assessment; 2) evaluating the impact of blood pressure variability, besides systolic/diastolic blood pressure, on the progression of the aggregate biomarker; 3) assessing whether specific classes of antihypertensive drugs differently affect the progression of the aggregate biomarker. In order to do this, this study proposes to evaluate advanced brain imaging and cognitive profile in a cohort of hypertensive patients, at baseline and after a 1 year follow up, to identify an innovative signature for the development of cognitive dysfunction in hypertension. In particular, the effects of blood pressure variability and of different classes of antihypertensive drugs will be evaluated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-14
• Study Start: 2019-12-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04
• Primary Completion: 2022-12-08
• Study Completion: 2022-12-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• age ≥ 40 and ≤ 70 years
• patients with moderate hypertension
• written informed consent

Exclusion Criteria

• previous IMA, stroke or TIA
• arrhythmia or severe cardiac disease
• Diabetes or renal disease
• psychiatric disease
• neurological or neurodegenerative disease
• dementia
• assumption of drugs known to interfere with cognitive function
• inability to be subjected MRI analysis
• participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypertensive patients	No interventions	Patients with SBP: 140-159; DBP: 90-99

Primary Outcome Measures

Name	Time	Method
Measurement of percentage change in diffusion parameters of the white matter	At Enrollment; at 1 year Follow-up	Fiber tracking by DTI MRI

Secondary Outcome Measures

Name	Time	Method
Detection of cognitive decline by decrease of MoCA score	At Enrollment; at 1 year Follow-up	Cognitive tests
Characterization of cardiac hypertensive organ damage progression	At Enrollment; at 1 year Follow-up	Echography
Characterization of renal hypertensive organ damage progression	At Enrollment; at 1 year Follow-up	eGFR
Characterization of Blood Pressure Variability	At Enrollment; at 1 year Follow-up	24h registration of systolic and diastolic blood pressure

Trial Locations

Locations (1)

IRCCS Neuromed; 🇮🇹 Pozzilli, Isernia, Italy