Hypertension
Conditions
Keywords
Hypertension, baroreceptor stimulation, Hypertension resistant
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.
Interventions
DEVICEBaroreceptor stimulation with Barostim Neo TM
Sponsors
Pr Patrick ROSSIGNOL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Microalbuminuria (mg/mmol creatinine) | 6 and 12 months | Comparison with usual care |
| cerebrovascular events (number of events) | baseline, 6 and 12 months | Comparison with usual care |
| Casual SBP (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 |
| Function and Left ventricular mass on echocardiography (g/m²) | 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 |
| 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 |
| Surgery Morbidity | 1 month | Clavien Dindo Scale, morbidity 1 month after surgery |
| Evolution of the kidney function (eGFR - MDRD - ml/min/1.73 m²) | 6 and 12 months | Comparison with usual care |
| kidney events (number of events) | baseline, 6 and 12 months | Comparison with usual care |
| Mean SBP 24h on ABPM (mmHg) | 6 and 12 months | Comparison with usual care |
| Mean nocturnal SBP on ABPM (mmHg) | 6 and 12 months | Comparison with usual care |
| Mean DBP 24h 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| ICER: difference in cost / difference in office systolic blood pressure (SBP) in mmHg | 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 | 6 and 12 months | Tolerance |
| Cost of unilateral carotid barostimulation including hospital stay | participants will be followed for the duration of hospital stay, an expected average of 2 days | — |
Countries
France
Outcome results
None listed