ESTIM-rHTN: Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Baroreceptor stimulation on top of the best medical care Baroreceptor stimulation with Barostim Neo TM |
Device: Baroreceptor stimulation with Barostim Neo TM
|
| No Intervention: Best medical care Best medical care |
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- Evolution of the kidney function (eGFR - MDRD - ml/min/1.73 m²) [6 and 12 months]
Comparison with usual care
- Microalbuminuria (mg/mmol creatinine) [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
- cerebrovascular events (number of events) [baseline, 6 and 12 months]
Comparison with usual care
- kidney events (number of events) [baseline, 6 and 12 months]
Comparison with usual care
Other Outcome Measures
- 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]
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Bordeaux | Bordeaux | France | ||
| 2 | Hôpital Arthur Gardiner | Dinard | France | ||
| 3 | CHU de Grenoble | Grenoble | France | ||
| 4 | CHRU de Lille | Lille | France | ||
| 5 | Hospices civils de Lyon | Lyon | France | ||
| 6 | APHM | Marseille | France | ||
| 7 | CHRU de Nancy | Nancy | France | ||
| 8 | APHP -Hotel Dieu hospital | Paris | France | 75000 | |
| 9 | GH la Pitié Salpêtrière | Paris | France | ||
| 10 | HEGP | Paris | France | ||
| 11 | CHU de Poitiers | Poitiers | France | ||
| 12 | CHU de RENNES | Rennes | France | 35033 | |
| 13 | CHU de Toulouse | Toulouse | France | ||
| 14 | Clinique Pasteur | Toulouse | France | ||
| 15 | CHRU de Tours | Tours | France |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
- Principal Investigator: Patrick ROSSIGNOL, Prof, CHRU Nancy
- Principal Investigator: Michel AZIZI, Prof, APHP-HEGP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2014-A00632-45