Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: Baroreceptor stimulation with Barostim Neo TM

• Registration Number: NCT02364310
• Lead Sponsor: Pr Patrick ROSSIGNOL

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Study Start: 2015-03-31
• Primary Completion: 2021-06-22
• Study Completion: 2021-06-22
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baroreceptor stimulation on top of the best medical care	Baroreceptor stimulation with Barostim Neo TM	Baroreceptor stimulation with Barostim Neo TM

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (15)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Hospices civils de Lyon; 🇫🇷 Lyon, France

Hôpital Arthur Gardiner; 🇫🇷 Dinard, France

CHRU de Lille; 🇫🇷 Lille, France

CHU de Grenoble; 🇫🇷 Grenoble, France

APHM; 🇫🇷 Marseille, France

APHP -Hotel Dieu hospital; 🇫🇷 Paris, France

CHRU de Nancy; 🇫🇷 Nancy, France

CHU de Poitiers; 🇫🇷 Poitiers, France

GH la Pitié Salpêtrière; 🇫🇷 Paris, France

HEGP; 🇫🇷 Paris, France

CHU de RENNES; 🇫🇷 Rennes, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHRU de Tours; 🇫🇷 Tours, France