Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation médico-économique de la Stimulation unilatérale du Sinus Carotidien Dans le Traitement de l'Hypertension artérielle résistante: Essai Multicentrique contrôlé, randomisé, Ouvert Avec évaluation d'efficacité Tensionnelle et de sécurité

Conditions
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Hypertension

Intervention / Treatment
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* Device: Baroreceptor stimulation with Barostim Neo TM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baroreceptor stimulation on top of the best medical care<br>Baroreceptor stimulation with Barostim Neo TM | Device: Baroreceptor stimulation with Barostim Neo TM<br> <br> |
| No Intervention: Best medical care<br>Best medical care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean SBP 24h on ABPM (mmHg) | Comparison with usual care | 6 and 12 months | 
| Mean nocturnal SBP on ABPM (mmHg) | Comparison with usual care | 6 and 12 months | 
| Mean DBP 24h on ABPM (mmHg) | Comparison with usual care | 6 and 12 months | 
| Mean diurnal DBP on ABPM (mmHg) | Comparison with usual care | 6 and 12 months | 
| Mean nocturnal DBP on ABPM (mmHg) | Comparison with usual care | 6 and 12 months | 
| Casual SBP (mmHg) | Comparison with usual care | 6 and 12 months | 
| Casual DBP (mmHg) | Comparison with usual care | 6 and 12 months | 
| Casual PP (mmHg) | Comparison with usual care | 6 and 12 months | 
| Pulse wave velocity (m/s) | Comparison with usual care | 6 and 12 months | 
| Central Pulse Pressure (mmHg) | Comparison with usual care | 6 and 12 months | 
| Function and Left ventricular mass on echocardiography (g/m²) | Comparison with usual care | 6 and 12 months | 
| Evolution of the kidney function (eGFR - MDRD - ml/min/1.73 m²) | Comparison with usual care | 6 and 12 months | 
| Microalbuminuria (mg/mmol creatinine) | Comparison with usual care | 6 and 12 months | 
| Antihypertensive regimen (Number of antihypertensive drugs) | Comparison with usual care | 6 and 12 months | 
| EuroQol5D (score) | Comparison with usual care | 6 and 12 months | 
| Cardiovascular events (number of events) | Comparison with usual care | baseline, 6 and 12 months | 
| Global cardiovascular risk (scale) | Comparison with usual care | 6 and 12 months | 
| Surgery Morbidity | Clavien Dindo Scale, morbidity 1 month after surgery | 1 month | 
| cerebrovascular events (number of events) | Comparison with usual care | baseline, 6 and 12 months | 
| kidney events (number of events) | Comparison with usual care | baseline, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, baroreceptor stimulation, Hypertension resistant