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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baroreceptor stimulation on top of the best medical care | Experimental | Baroreceptor stimulation with Barostim Neo TM |
|
| Best medical care | No Intervention | Best medical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baroreceptor stimulation with Barostim Neo TM | Device |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of unilateral carotid barostimulation including hospital stay | participants will be followed for the duration of hospital stay, an expected average of 2 days | |
| ICER: difference in cost / difference in office systolic blood pressure (SBP) in mmHg | 12 months |
Main inclusion Criteria:
Main exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick ROSSIGNOL, Prof | CHRU Nancy | Principal Investigator |
| Michel AZIZI, Prof | APHP-HEGP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France | ||||
| Hôpital Arthur Gardiner |
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| 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 |
| ICER/ICER: difference in cost / difference in QALY (quality-of-life-adjusted survival based on the clinical trial data and the modeling results) for the lifetime modeling | 12 months |
| Budget impact (cost in Euros) | 4 years |
| Number of outpatient visits for hypertension management in both groups | 12 months |
| Morbidity | Tolerance | 6 and 12 months |
| Dinard |
| France |
| CHU de Grenoble | Grenoble | France |
| CHRU de Lille | Lille | France |
| Hospices civils de Lyon | Lyon | France |
| APHM | Marseille | France |
| CHRU de Nancy | Nancy | France |
| APHP -Hotel Dieu hospital | Paris | 75000 | France |
| GH la Pitié Salpêtrière | Paris | France |
| HEGP | Paris | France |
| CHU de Poitiers | Poitiers | France |
| CHU de RENNES | Rennes | 35033 | France |
| CHU de Toulouse | Toulouse | France |
| Clinique Pasteur | Toulouse | France |
| CHRU de Tours | Tours | France |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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