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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60-88
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 ...)

Trial design

Design model

Parallel

Treatments tested in this trial

  • blood pressure lowering algorithm

    Other intervention

    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

    Other intervention

    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.

Treatment groups

820 Participants
are divided into 2 treatment groups
Group A: blood pressure lowering algorithmExperimental treatment 1 intervention
Group B: usual strategyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
36 months + 6 months max

Secondary outcomes

1

Imaging criteria : changes in the number of large or confluent WML

Time frame
36 months+ 6 months max
2

Imaging criteria : changes in the volume of WML depending on their location (periventricular and deep white matter)

Time frame
36 months+ 6 months max
3

Imaging criteria : changes in the number of silent infarctus

Time frame
36 months+ 6 months max
4

Imaging criteria : changes in the number of microbleeds

Time frame
36 months+ 6 months max

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.