NCT02364310已完成不适用
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
Pr Patrick ROSSIGNOL17 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2015年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 17
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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)
时间窗: 12 months
次要结局
- Evolution of the kidney function (eGFR - MDRD - ml/min/1.73 m²)(6 and 12 months)
- Mean nocturnal SBP on ABPM (mmHg)(6 and 12 months)
- Mean diurnal DBP on ABPM (mmHg)(6 and 12 months)
- Mean nocturnal DBP on ABPM (mmHg)(6 and 12 months)
- Function and Left ventricular mass on echocardiography (g/m²)(6 and 12 months)
- Microalbuminuria (mg/mmol creatinine)(6 and 12 months)
- Surgery Morbidity(1 month)
- kidney events (number of events)(baseline, 6 and 12 months)
- Casual SBP (mmHg)(6 and 12 months)
- Mean SBP 24h on ABPM (mmHg)(6 and 12 months)
- Cardiovascular events (number of events)(baseline, 6 and 12 months)
- Global cardiovascular risk (scale)(6 and 12 months)
- Mean DBP 24h on ABPM (mmHg)(6 and 12 months)
- Casual DBP (mmHg)(6 and 12 months)
- Casual PP (mmHg)(6 and 12 months)
- Pulse wave velocity (m/s)(6 and 12 months)
- Central Pulse Pressure (mmHg)(6 and 12 months)
- Antihypertensive regimen (Number of antihypertensive drugs)(6 and 12 months)
- EuroQol5D (score)(6 and 12 months)
- cerebrovascular events (number of events)(baseline, 6 and 12 months)
研究者
Pr Patrick ROSSIGNOL
PU-PH
Central Hospital, Nancy, France
研究点 (17)
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