Hypertension
Conditions
Keywords
Vascular Cognitive Impairment, Magnetic Resonance Imaging, Blood Pressure Variability
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.
Interventions
OTHERNo interventions
No interventions - observational study
Sponsors
IRCCS Multimedica
Neuromed IRCCS
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of percentage change in diffusion parameters of the white matter | At Enrollment; at 1 year Follow-up | Fiber tracking by DTI MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactGiuseppe Lembo, MD, PhD
Outcome results
None listed