Impact of Patient-specific and Procedural Characteristics Like Catecholamine Spill-over on the Long-term Outcome After Renal Denervation and EP Ablation
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Catecholamine norepinephrine and epinephrine (pg/ml)
研究概览
简要总结
Despite a rapidly increasing number of renal denervation (RDN) procedures, only little is known regarding the patient or procedural characteristics influencing the outcome. None of the detectable variables like number of ablation points, temperature rise, impedance drop, have been shown to correlate with the blood pressure (BP) reduction. In this study, the investigators assess different patient and procedural characteristics, like exact patient medication, stress hormones, heart rate variability, and focus on the change of the catecholamine spill-over, and the impact on BP and heart rate after RDN and after EP ablation. The investigators hypothesize the correlation between reduction of catecholamine spill-over due to denervation and the BP reduction. In this study, the investigators will assess 40 patients undergoing RDN and 40 patients undergoing EP ablation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •medically-indicated renal denervation
- •Age over 18 years
- •written informed consent
排除标准
- •pregnancy
- •expected compliance problems
- •current participation in other studies
结局指标
主要结局
Catecholamine norepinephrine and epinephrine (pg/ml)
时间窗: 2 years
Measurement the differences of norepinephrine and epinephrine (pg/ml) in the renal vein and artery before and after the ablation
次要结局
- Impact of the ablation on 24-hour blood pressure (mmHg) and heart rate (beats/min)(2 years)
研究者
Tiroch, Klaus
Privatdozent Dr. med.
University of Witten/Herdecke