Clinical trial NCT02364310: Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
baroreceptor stimulation
Hypertension resistant
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 12 months
Secondary outcomes:
measure: Mean SBP 24h on ABPM (mmHg)
timeFrame: 6 and 12 months
measure: Mean nocturnal SBP on ABPM (mmHg)
timeFrame: 6 and 12 months
measure: Mean DBP 24h on ABPM (mmHg)
timeFrame: 6 and 12 months
measure: Mean diurnal DBP on ABPM (mmHg)
timeFrame: 6 and 12 months
measure: Mean nocturnal DBP on ABPM (mmHg)
timeFrame: 6 and 12 months
measure: Casual SBP (mmHg)
timeFrame: 6 and 12 months
measure: Casual DBP (mmHg)
timeFrame: 6 and 12 months
measure: Casual PP (mmHg)
timeFrame: 6 and 12 months
measure: Pulse wave velocity (m/s)
timeFrame: 6 and 12 months
measure: Central Pulse Pressure (mmHg)
timeFrame: 6 and 12 months
measure: Function and Left ventricular mass on echocardiography (g/m²)
timeFrame: 6 and 12 months
measure: Evolution of the kidney function (eGFR - MDRD - ml/min/1.73 m²)
timeFrame: 6 and 12 months
measure: Microalbuminuria (mg/mmol creatinine)
timeFrame: 6 and 12 months
measure: Antihypertensive regimen (Number of antihypertensive drugs)
timeFrame: 6 and 12 months
measure: EuroQol5D (score)
timeFrame: 6 and 12 months
measure: Cardiovascular events (number of events)
timeFrame: baseline, 6 and 12 months
measure: Global cardiovascular risk (scale)
timeFrame: 6 and 12 months
measure: Surgery Morbidity
timeFrame: 1 month
measure: cerebrovascular events (number of events)
timeFrame: baseline, 6 and 12 months
measure: kidney events (number of events)
timeFrame: baseline, 6 and 12 months
Other outcomes:
measure: Cost of unilateral carotid barostimulation including hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 days
measure: ICER: difference in cost / difference in office systolic blood pressure (SBP) in mmHg
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Budget impact (cost in Euros)
timeFrame: 4 years
measure: Number of outpatient visits for hypertension management in both groups
timeFrame: 12 months
measure: Morbidity
timeFrame: 6 and 12 months
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Dinard
country: France
facility: Hôpital Arthur Gardiner
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: Hospices civils de Lyon
city: Marseille
country: France
facility: APHM
city: Nancy
country: France
facility: CHRU de Nancy
city: Paris
country: France
facility: APHP -Hotel Dieu hospital
city: Paris
country: France
facility: GH la Pitié Salpêtrière
city: Paris
country: France
facility: HEGP
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU de RENNES
city: Toulouse
country: France
facility: CHU de Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: CHRU Nancy
name: Patrick ROSSIGNOL, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP-HEGP
name: Michel AZIZI, Prof
role: PRINCIPAL_INVESTIGATOR
References: