Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals

  • STATUS
    Recruiting
  • End date
    Sep 11, 2024
  • participants needed
    820
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 8 May 2021
hypertension
combinations
calcium
antihypertensive drugs

Summary

The purpose of the study is to test the hypothesis of slowing the progression of White Matter Lesions (WML) by lowering blood pressure (BP) in patients with cognitive complaints and a moderate to high grade of WML on brain MRI.

Description

SCIENTIFIC BACKGROUND: White Matter Lesions (WML) are cerebrovascular abnormalities discovered on MRI that are associated with an increased risk of dementia. High blood pressure (BP) is a major risk factor for WML. WML are therefore key lesions in the causal chain linking vascular factors and dementia, particularly Alzheimer's disease.

However, it has not been shown that lowering BP could limit the progression of the WML in people with cognitive impairment.

OBJECTIVES: To test the hypothesis of slowing progression of WML by lowering BP in patients with memory complaints with a moderate to high grade of WML on brain MRI.

STUDY DESIGN: PROBE (Prospective randomized open blinded end-point) trial. Blind reading of both MRI for every patient in each group. After stratified randomization on age, sex and center, patients will be assigned to two strategies:

  • Reinforced Group (RG): enhanced strategy aiming at a systolic BP <135 mmHg;
  • Usual Group (UG): usual strategy based on the usual routine care.

SAMPLE SIZE: patients will be enrolled (410 in each arm) in 12 Memory Resources and Research Center (CMRR) with access to 1.5 T or more MRI.

CONDUCT OF THE STUDY:

Duration of the inclusion period: 71 months and 2 weeks. Patient participation duration: 36 months +/- 2 weeks Total study duration: 9 years. Clinical and para-clinical evaluation: MRI as part of research at the beginning of the study and before the end of the study at 36 months (primary endpoint); Clinical evaluation of neuropsychological tests at the beginning of the study and yearly ; walking speed measurement single leg stance balance test ; repeated BP measurements; monitoring of neurological signs and symptoms; blood test at the beginning of the study (electrolytes, lipid profiles, fasting blood glucose, if not existing); MRI if not existing for validation of the inclusion criterion and performed in the ordinary course.

Details
Condition Vascular Diseases, Cerebrovascular disease, cerebrovascular diseases
Treatment blood pressure lowering algorithm, usual strategy
Clinical Study IdentifierNCT02472028
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on8 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

to 88 years old patients
Patient with cognitive complaint with MMSE 20performed within 6 months prior to enrollment (with or without dementia)
Patient with a socio-educational level 3
Presence of hyperintensities of moderate to high grade on the last MRI or old scan (grades C and D on the modified Scheltens scale, grades 2/3 Fazekas)
Hypertension defined by a Systolic Blood Pressure (SBP) and / or a Diastolic Blood Pressure (DBP) 140/90 mmHg, treated or not
Affiliation to a social security system
Informed consent given, signed consent

Exclusion Criteria

Presence of severe orthostatic hypotension defined as a decrease of 30 mmHg in SBP standing within 3 minutes
Contraindication to MRI (presence of ferromagnetic foreign body (especially some intracranial clips, some heart valves, intraocular foreign bodies, metal prosthesis), subject carrying pacemaker, claustrophobic participants)
Severe diseases associated with a life expectancy of less than 3 months
Major physical impairments that can interfere with the feasibility of the tests (sight, hearing ...)
Presence of another dementia different than Alzheimer's disease vascular dementia or mixed dementia
Persons under guardianship
Secondary hypertension: renovascular hypertension, primary aldosteronism, pheochromocytoma
Patient already receiving 4 or more antihypertensive drugs at maximum dosage
Patient participating in another clinical research study on drug requiring exclusion period
severe renal impairment
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