Renal Denervation - Hope for Patients With Refractory Hypertension?
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- Blood pressure difference
研究概览
简要总结
Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Refractory hypertension with office SBP > 140 mmHg
- •SBP > 130 during 24-hours Holter blood pressure monitoring
- •Treatment with the least 3 antihypertensive medications including diuretics in optimal doses
- •Age > 18 years
- •Signed informed consent
排除标准
- •Secondary forms of hypertension
- •Chronic renal disease (serum creatinine > 200 umol/l)
- •Pregnancy
- •History of myocardial infarction or stroke in last 6 months
- •Severe valvular stenotic disease
- •Anatomic abnormalities and variants of renal artery including aneurysms, severe stenosis, reference diameter < 4 mm or length < 20 mm
- •Increased bleeding risk (thrombocytopenia < 50, INR > 1.5)
研究组 & 干预措施
Renal denervation
Renal denervation (Symplicity® Catheter System™) + conventional antihypertensive medical treatment without spironolactone (spironolactone can be taken only if started before randomization)
干预措施: Renal denervation (Symplicity® Catheter System™) (Device)
Medical treatment
Conventional antihypertensive treatment including spironolactone (if not contraindicated).
One year after randomization, renal denervation can be performed according to the physician's decision based on the BP levels and if patient desires the procedure.
结局指标
主要结局
Blood pressure difference
时间窗: 6 months
Systolic and Diastolic blood pressure difference between baseline and 6 months post-randomization. Blood pressure will be evaluated using 24-hours monitoring.
次要结局
- Change of blood laboratory parameters and renal function(6 months, 1, 2, 3 years)
- Post-denervation renal anatomy assessment(1 year)
- Blood pressure differences similar to primary outcome(1 year, 2 years, 3 years)
研究者
Petr Widimsky, MD
Head of Cardiocenter, 3rd Faculty of Medicine
Charles University, Czech Republic