A Pragmatic Randomized Clinical Evaluation of Renal Denervation for Treatment Resistant Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Average systolic 24-hour ambulatory blood pressure
研究概览
简要总结
The purpose of this study is to evaluate the clinical and economic impact of implementation of renal denervation with the Symplicity™ Catheter System for treatment-resistant hypertension in Ontario, Canada.
详细描述
This is a pragmatic randomized trial of renal nerve denervation for treatment resistant hypertension. This is part of a ministry sponsored MaRS-EXCITE program, to conduct early market health technology assessment, in order to determine appropriateness for provincial funding. We will assess the effectiveness, safety, economic attractiveness and feasibility of implementation of renal nerve denervation for treatment resistant hypertension. This will involve a new model of care which will include a multi-disciplinary team approach to these patients. Treatment resistant hypertension is defined as patients with uncontrolled hypertension despite being on optimal doses of 3 or more anti-hypertensive medications. Patients will be randomized to either standard treatment or renal nerve denervation and followed for 6 months to determine impact on blood pressure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ontario residents
- •Aged 18 and over
- •Diagnosis of treatment-resistant hypertension after assessment and optimization by a hypertension specialist following recommended evaluation and diagnosis as outlined by the American Heart Association
- •Office systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for patients with type II diabetes mellitus) prior to optimization by a hypertension specialist
- •Baseline average systolic 24 hour ambulatory blood pressure of ≥ 135 mmHg after optimization and prior to randomization
- •Prescribed 3 or more antihypertensive medications of different classes, both prior to optimization and at randomization, one of which must be a diuretic (a medication can be counted more than once if it acts on different receptors)
- •Suitable renal artery anatomy based on CT/MRI/renal angiography imaging: both renal arteries > 20 mm in length and > 4 mm in diameter without significant fibromuscular disease or renal artery stenosis (>50%)
排除标准
- •Secondary causes of hypertension:
- •Primary aldosteronism (secondary to adrenal adenoma)
- •Chronic kidney disease: creatinine clearance or eGFR < 45 ml/min/1.73m² (measured on 24 hour urine preferably or MDRD)
- •Pheochromocytoma
- •Cushing's syndrome
- •Aortic coarctation (differential in brachial or femoral pulses, systolic bruit)
- •Type 1 diabetes mellitus
- •Pregnancy
结局指标
主要结局
Average systolic 24-hour ambulatory blood pressure
时间窗: 6 months
次要结局
- Average office blood pressure using an approved, automated office blood pressure device(6 months)
- Peri-procedural mean cost per patient in Canadian dollars(12 months)
- Hypertensive medication complexity index (MRCI)(6 months)
- Body Mass Index (BMI)(6 months)
- Vascular complications (dissection, pseudoaneurysm, AV fistula)(6 months)
- Average daytime and average night-time systolic ambulatory blood pressure(6 months)
- Number of hypertensive medications(6 months)
- Composite cardiovascular endpoints (fatal & non-fatal MI, new onset heart failure, stroke, beginning dialysis, hospitalization for cardiovascular/renal reasons, increase in hypertension medications)(6 months)
- 24-hour urine sodium (% change from baseline)(6 months)
- Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) for early intervention group(6 months)
- Proportion of patients achieving target systolic blood pressure (on average 24-hour ambulatory blood pressure of <130 mmHg) on the same or fewer medications at the time of randomization(6 months)
- Variability of 24-hour ambulatory systolic blood pressure(6 months)
- Generic quality of life (EQ-5D)(6 months)
- 24-hour urine sodium(6 months)
- Acute periprocedural renal injury(72 hours post procedure)
- Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area)(6 months)
- Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline)(6 months)
研究者
Dr. Harindra Wijeysundera
Interventional Cardiologist
Sunnybrook Health Sciences Centre