RecruitingPhase 4NCT02472028

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

LEukoaraiosis and blOod Pressure Reduction in OLD People

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

820 participants

Start Date

Sep 1, 2015

Study Type

INTERVENTIONAL

Conditions

Cerebrovascular Disorders

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.

Eligibility

Min Age: 60 YearsMax Age: 88 Years

Inclusion Criteria7

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 Criteria10

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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Interventions

OTHERblood pressure lowering algorithm

The treatments used in the "enhanced strategy" arm are those proposed by national (HAS2013, SFHTA2013) and international (ESH 2013) recommendations, according to their Marketing Authorization and Summary of Product Characteristics : Diuretics, beta-blockers, Angiotensin Converting Enzyme inhibitors, Angiotensin Receptor Blockers, Calcium Channel Blockers Throughout the study, choice of drugs in each therapeutic class is left on the investigator's initiative. All drugs of these classes may be used , no specific drug is tested in this study.

OTHERusual strategy

The implementation of antihypertensive therapy the current recommendations to reach the blood pressure target in usual care. Throughout the study, choice of drugs in each therapeutic class is left on the investigator's initiative. Combinations of different pharmacological classes can be tested in order to find the most effective and best tolerated combinations.