Objective
The CAHRE-Risk trial is designed to demonstrate that the reduction of left ventricular hypertrophy (LVH) by a simple-to-use treatment which does not alter quality of life, offers a better control of cardiovascular future in high risk subjects, thus that electrocardiographically (ECG) defined LVH is a suitable surrogate endpoint.
Cardiovascular risk remains an important health public issue in developed countries, despite of the advancement of therapeutics. It is well established that (i) left ventricular hypertrophy (LVH) is a risk factor for cardiovascular morbi-mortality (including myocardial infarction and stroke) and (ii) LVH is common, especially in hypertensive subjects. The predictive value of LVH for cardiovascular risk remains even after allowance for the other risk factors (including blood pressure), and also in treated hypertensives.
ACE decrease blood pressure, but how they affect cardiovascular risk associated with hypertension is not yet known. Some experimental data suggest that, in animal and in human, low-dose ACE inhibitors reduce LVH, independently of any effect on blood pressure. Thus, it is the choice treatment to test if LVH is a suitable surrogate end-point for reduced cadiovascular risk, i.e. if the control of LVH decreases cardiovascular risk. This is a central question, since to date there is no proof that LVH reduction is favorable, although many physicians and scientists accept this as a scientifically validated fact. A large randomized placebo-controlled clinical trial is the only way to test this assumption. The CAHRE-Risk trial will include 3200 controlled treated hypertensive subjects, with electrocardiography evidence of LVH, with wide inclusion criteria to ensure as much as possible the generalisability of the results. This is a randomized, placebo controlled, in parallel group trial, where patients will be included for a follow-up of five years. The main outcome combines cardiovascular morbi-mortality criteria, which expected incidence is 15% in the control group. The tested treatment is an angiotensin converting enzyme inhibitor given at low-dose, to obtain a LVH regression irrespective of any antihypertensive effect. The expected relative risk reduction is of 25%, for a risk alpha of 5% and a power of 90%.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine cardiology cardiovascular diseases
- medical and health sciences basic medicine neurology stroke
- natural sciences biological sciences biochemistry biomolecules proteins enzymes
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Coordinator
69394 LYON
France
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