NCT02164435Unknown不适用
Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cardiac Function (evaluated by MRI)
研究概览
简要总结
This is a prospective, single centre clinical investigation looking at short (6 months) and long term (24 months) changes in cardiac function and renal function in patients with drug-resistant hypertension post renal sympathetic denervation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be able and willing to comply with the required follow-up schedule
- •Therapeutic Goods Association approved indications for EnligHTN™ Renal Denervation System
- •Subject is ≥ 18 years of age at time of consent Subject has office SBP ≥ 160 mmHg (except for subjects with Diabetes Mellitus who must demonstrate an office SBP of ≥ 150 mm Hg) within 14 days of the procedure ◦Subject is taking ≥ 3 antihypertensive medications concurrently at maximum tolerated dose (this must include one diuretic) or subject has a documented intolerance to at least 2 out of the 4 major classes of anti-hypertensives (ACE/ARB, CCB, Diuretics, Beta Blockers and is unable to take 3 antihypertensive drugs.
排除标准
- •Standard CMR exclusions;
- •implanted cardiac device
- •intracranial metallic implants
- •claustrophobia -Gadolinium-specific: estimated GFR <60 mls/min (usual clinical cut-off is <30 mls/min).
- •Adenosine-specific:
- •asthma / reactive airways disease
- •>first degree atrioventricular block
- •concomitant use of dipyridamole or theophylline consumption of caffeine within 48 hours of proposed investigation
- •EnligHTN™ Renal Denervation System exclusion criteria:
- •Subject has an identified cause of secondary hypertension
- •Subject has an estimated GFR <45 mL/min per 1.73 m2 using the MDRD formula
- •Subject has undergone prior renal angioplasty, indwelling renal stents, and/or aortic stent grafts
- •Subject has haemodynamically significant valvular heart disease
- •Subject has a life expectancy less than 12 months, as determined by the PI
- •Subject is participating in another clinical study Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
- •Subject has renal arteries with diameter(s) < 4 mm in diameter
结局指标
主要结局
Cardiac Function (evaluated by MRI)
时间窗: Baseline and 6 Months
MRI Indices of Cardiac Function * Myocardial mass and myocardial fibrosis * Atrial and ventricular ejection function * Myocardial perfusion * Arterial distensibility
次要结局
- Renal Function (evaluated by MRI)(Baseline, 6 Months and 24 Months)
- Cardiac Function(Baseline and 24 Months)
研究者
Stephen Grant Worthley
Helpman Chair of Cardiovascular Medicine
University of Adelaide
研究点 (2)
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