Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN

Pr Patrick ROSSIGNOL132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Hypertension

Interventions

Baroreceptor stimulation with Barostim Neo TMDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (15)

CHU de Bordeaux

Bordeaux, France

Hôpital Arthur Gardiner

Dinard, France

CHU de Grenoble

Grenoble, France

Outcomes

Primary Outcomes

12th month diurnal SBP (mmHg) measured on ABPM, adjusted on baseline SBP, also used to compute the incremental cost-effective ratio (to identify the extra cost of unilateral carotid barostimulation in BP reduction compared to usual care)

Time frame: 12 months

Secondary Outcomes

Mean SBP 24h on ABPM (mmHg)

Comparison with usual care

Time frame: 6 and 12 months

Mean nocturnal SBP on ABPM (mmHg)

Comparison with usual care

Time frame: 6 and 12 months

Mean DBP 24h on ABPM (mmHg)

Comparison with usual care

Time frame: 6 and 12 months

Mean diurnal DBP on ABPM (mmHg)

Comparison with usual care

Time frame: 6 and 12 months

Mean nocturnal DBP on ABPM (mmHg)

Comparison with usual care

Time frame: 6 and 12 months

Casual SBP (mmHg)

Comparison with usual care

Time frame: 6 and 12 months

Casual DBP (mmHg)

Comparison with usual care

Time frame: 6 and 12 months

Casual PP (mmHg)

Comparison with usual care

Time frame: 6 and 12 months

Data from ClinicalTrials.gov

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