Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN (ESTIM-rHTN)

Pr Patrick ROSSIGNOL

Status

Completed

Conditions

Hypertension

Treatments

Device: Baroreceptor stimulation with Barostim Neo TM

Study type

Interventional

Funder types

Other

Identifiers

NCT02364310

2014-A00632-45

Details and patient eligibility

About

Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation with Barostim NeoTM compared to usual care in patients with resistant hypertension (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long modeling.

Enrollment

132 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion Criteria:

18-85 years old men or women
Resistant hypertension on 4 medications incl. thiazide or thiazide-like diuretics at appropriate doses + spironolactone (unless spironolactone intolerance)
Essential hypertension documented (bilan < 2 years old)
eGFR ≥ 30 ml/min/1,73 m2
No carotid condition associated with a contra-indication for Barostim NeoTM use

Main exclusion Criteria:

Patients with documented secondary hypertension, besides Obstructive Sleep Apnea
Symptomatic orthostatic hypotension
Patient with prior syncope or myocardial infarction, unstable angina pectoris, or cerebrovascular within 3 months before inclusion
Patient with type 1 diabetes mellitus
Patient with permanent atrial fibrillation
Patient with brachial circumference of ≥ 46cm
Patient with BMI>45kg/m2
Pregnancy, breastfeeding or planning a pregnancy within 2 years
NeoTM implantation anatomic contra-indications