Renal Sympathetic Denervation Restores Autonomic Imbalance and Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Atrial fibrillation
研究概览
简要总结
The autonomic nervous system plays an important role in the precipitation of AF in structurally-abnormal hearts. Restoration of autonomic imbalance may therefore prevent new-onset AF.
Renal artery denervation (RDN) is a novel percutaneous procedure that uses radio-frequency energy to destroy the sympathetic renal nerves. Symplicity 1 and -2 studies have shown that RDN effectively reduces blood pressure in up to 80% of treated patients. LVH regression and improvement of diastolic dysfunction follow as a consequence of afterload reduction and renin-angiotensin-aldosterone system modulation. RDN may thus also reduce intra-atrial pressure resulting in less stretch of the pulmonary venous ostia where most ectopic AF-foci originate.
Hypothesis: RDN restores autonomic imbalance in HTHD and lowers intra-atrial pressure by reducing afterload. These synergistic mechanisms may prevent new-onset AF.
详细描述
One hundred consenting patients meeting all inclusion criteria will undergo an exercise stress test, 2D and M-Mode echocardiograms and 24-hour ambulatory blood pressure holter monitoring prior to being randomised to receive either renal denervation (RDN) with a Symplicity renal denervation catheter plus medical therapy or medical therapy alone. Coronary angiography with/without coronary revascularisation will be performed as per the treating cardiologist's clinical judgement and a Reveal® holter will be implanted in all patients at the end of the procedure.
Time zero will be defined as starting at three months after the procedure. Follow up visits will be scheduled to scan the holter for the primary end point, i.e. high atrial rates (AF-surrogate defined as: "episodes of atrial rate >190 beats per minute for more than 6 minutes") or new-onset AF. Patients will be followed six monthly for three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have an indication for coronary angiography e.g.
- •Acute coronary syndrome
- •Positive stress ECG: - Defined as ≥1mm ST segment shift (depression or elevation) in ≥2 contiguous leads with/without chest discomfort)
- •Age ≥55 years
- •Office blood pressure ≥160/90mmHg in non-diabetics or ≥150/90mmHg in diabetics
- •Subjects must be on at least 3 anti-hypertensive drugs, including a diuretic agent
- •Sinus rhythm
- •Left ventricular hypertrophy defined on echo as:
- •Estimated LV mass > 255 g or LVMI >131 g/m2 for men
- •Estimated LV mass >193 g or LVMI >113 g/m2for women
- •Left atrial diameter ≥45mm on any echocardiographic window
排除标准
- •Estimated glomerular filtration rate (eGFR) < 45ml/min/1.73m2
- •Renal artery anatomy unsuitable for RDN
- •Substantial stenotic valvular heart disease
- •Pregnancy or planned pregnancy
- •Thyrotoxicosis
- •Patients needing to undergo coronary artery bypass surgery
研究组 & 干预措施
Renal denervation
Renal denervation: both renal arteries are denervated by applying radio-frequency energy at application points moving in a helical fashion starting in the distal renal artery and moving to the proximal junction with the abdominal aorta.
干预措施: Renal denervation (Device)
Renal denervation
Renal denervation: both renal arteries are denervated by applying radio-frequency energy at application points moving in a helical fashion starting in the distal renal artery and moving to the proximal junction with the abdominal aorta.
干预措施: Medical therapy (Drug)
Medical therapy
This group will not receive renal sympathetic denervation
干预措施: Medical therapy (Drug)
结局指标
主要结局
Atrial fibrillation
时间窗: 3 years
Subclinical atrial tachyarrhythmias (episodes of atrial rate \>190 beats per minute for more than 6 minutes) or atrial fibrillation recorded by implantable loop recorder (Reveal® holter).
次要结局
- Restoration of autonomic imbalance(3 years)
研究者
Marshall Jacobus Heradien
Dr
Pace Clinic