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

NCT02472028 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Phase 4

Started

2015-09

Last updated

2025-09-05

Condition(s) studied

Cerebrovascular Disorders

Investigational drug(s) / intervention(s)

blood pressure lowering algorithmusual strategy

blood 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.

usual 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.

Study 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

Sex

ALL

Min age

60 Years

Max age

88 Years

Healthy volunteers

Inclusion Criteria: * 60 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

Primary outcome measure(s)

The main criterion is based on the quantitative assessment of White Matter Lesions (WML) volumes at the beginning and at the end of the study for each patient and each arm of the trial. The WML volume from the final MRI is compared to that of the initial — 36 months + 6 months max

Trial sites (2)

Facility	City	Region	Status
Memory for Research and Resources Center / Neuroscience pole	Bordeaux	Pellegrin Hospital Group	Not Yet Recruiting
Memory Resources Centre and South of Ile de France Search - Broca Hospital	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02472028 on ClinicalTrials.gov ↗ ← All trials in France