Association Between a Multi-Gene Panel and Renal Denervation Effectiveness in Patients With Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Correlation between genetic scoring and RDN effectiveness using office blood pressure
研究概览
简要总结
The purpose of this study is to assess the effectiveness of a multi-gene panel to determine which subjects are likely to respond to renal denervation therapy with Medtronic's Symplicity Spyral™ multi-electrode renal denervation system.
详细描述
The objective of this study is to assess if renal denervation (RDN) effectiveness using the Symplicity SpyralTM multi-electrode renal denervation system is associated with ranked genomic scoring from the Geneticure multi-gene algorithm for renal denervation. The present study will assess if subjects who have a high genetic score, based on the hypothesized importance of the organ systems involved, will have differential responsiveness to RDN in a descending order. The genetic scoring is collectively ranked in a specific order, in that:
- Subjects with a "high level of general functionality" (functionality in the sympathetic nervous system (SNS), cardiac, vascular (renin-angiotensin-aldosterone system (RAAS)), and renal system genotypes will be most responsive to RDN.
- Subjects with high number of functional genotypes of SNS, cardiac, and RAAS will be the next most responsive group.
- Subjects with functionality in genotypes of SNS and cardiac systems will demonstrate the next most responsive group.
- Subjects with functionality in the SNS genotypes will demonstrate some degree of responsiveness.
- Subjects with functionality in the renal system, but not SNS, cardiac, nor RAAS, will be the least responsive to this therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is currently or has previously been enrolled in a Medtronic clinical study utilizing the Symplicity Spyral™ multi-electrode renal denervation system.
- •Subject received Renal Denervation.
- •Subject has met the primary efficacy endpoint for the Medtronic Symplicity Spyral study and which arm they were randomized to.
- •Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
排除标准
- •Unable to provide written, informed, consent
结局指标
主要结局
Correlation between genetic scoring and RDN effectiveness using office blood pressure
时间窗: 6 months
Change in office blood pressure (mmHg) from baseline to post- renal denervation procedure in subjects who have met the primary efficacy endpoints in the Symplicity Spyral studies (3-months for the HTN-OFF MED trial and 6-months for the HTN-ON MED trial) according to ranked genetic score values.
Correlation between genetic scoring and RDN effectiveness using ambulatory blood pressure
时间窗: 6 months
Change in ambulatory blood pressure (mmHg) from baseline to post- renal denervation procedure in subjects who have met the primary efficacy endpoints in the Symplicity Spyral studies (3-months for the HTN-OFF MED trial and 6-months for the HTN-ON MED trial) according to ranked genetic score values.
次要结局
未报告次要终点