Clinical research project: ESTIM-rHTN

" Medico-economic evaluation of unilateral carotid sinus stimulation in the treatment of resistant hypertension: a multicentre, randomised, open-label, controlled trial with blood pressure efficacy and safety assessment (IDRCB: 2014-A00632-45)"

• You are under 85 years old,
• You are currently being treated for high blood pressure,
• Your blood pressure remains high (> 140 mmHg systolic blood pressure and/or > 90 mmHg diastolic blood pressure) despite taking at least three antihypertensive drugs,

The CHRU of NANCY and several Centres of Excellence in Arterial Hypertension of the French Society of Arterial Hypertension invite you to participate in the ESTIM-rHTN clinical trial promoted by the CHRU of Nancy and approved by the health authorities.

What is the purpose of this research?

This study, which has the support of the Ministry of Health, aims to evaluate the efficacy and safety of an implantable medical device Barostim neo™in hypertension compared to usual management.

This study will also make it possible to evaluate the place and interest that the Barostim neo™implantable medical device can take in relation to exclusive drug treatment with regard to the management of this disease already existing in France.

How does barostimulation work?

The system Barostim neo™ is a CE marked implantable device designed to stimulate the body's natural cardiovascular regulators called "baroreceptors" (blood pressure receptors) thereby lowering blood pressure.

It consists of placing a small pellet (electrode) connected to a battery (the barostimulator) under the skin in an artery in the neck; this is called an implantable device. It is therefore a surgical treatment and is not a drug.

The pacemaker resembles the cardiac pacemakers that are commonly used to treat certain heart diseases.

The surgical procedure is short, similar to the placement of a heart pacemaker, and is reversible, meaning that it can be removed or deactivated at any time for any reason.

 What does this research involve?

This study is being conducted in two groups of patients with poorly controlled hypertension despite taking antihypertensive medication: a group treated with usual antihypertensive treatments according to current recommendations and a group treated with the Barostim neo™ medical device in addition to usual antihypertensive treatments. The group allocation is random (i.e. the study group to which you will belong will not depend on you or the study doctor, but will be pre-determined by computerized randomization). You will have specialised follow-up at a study centre (maximum 7 visits) for 12 months.)

How to participate in this clinical trial?

Contact your nearest Study Centre

 

Clinical research (involving the human person) is conducted in strict compliance with the ethics and legislation in force.

This research is funded by the Ministry of Health (Medico-economic Research Programme 2013 (PRME-13-0260))