FRiEND Registry: Real Life Data From Hypertensive Patients Treated With Renal Denervation in Current Practice in France- French RENal Denervation Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in SBP measured by HBPM before and after RDN (1 year).
研究概览
简要总结
Renal denervation (RDN) is a recent procedure that can be used to control BP (blood pressure) in hypertensive patients. Numerous publications from randomised trials have demonstrated the efficacy of RDN in this indication. The latest guidelines now include RDN as an effective technique for use in hypertension. Since early 2023, RDN using Medtronic's Spiral radiofrequency system has benefited from transitional authorisation for reimbursement by the French health insurance system. An application for reimbursement is underway for the ultrasound system. We aim to compile an exhaustive prospective register of all procedures carried out in France over the next few years, regardless of the type of catheter used or the context in which the procedure was carried out (transitional reimbursement, industrial register, randomised trial). Our aim is to assess the efficacy and safety of the procedure within the French healthcare system, the characteristics of patients benefiting from the procedure, the centres performing renal denervation, and the care pathways used, and to be able to present all this data, independently of the industry, to the healthcare authorities when it comes time to reassess the value of this procedure and its indications. The goal of this observational study is to learn about changes in blood pressure in patient with high blood pressure before and 1 year after a renal denervation treatment (RDN).
The primary endpoint is to describe changes in systolic blood pressure (SBP) measured by Home Blood Pressure Measurement (HBPM) in patients suffering from high blood pressure, before and 1 year after RDN.
详细描述
This study concerns patients with high blood pressure who have been treated with renal denervation since January 2010 or who will undergo renal denervation after March 2025.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adult ( > 18 years old) hypertensive patients treated with RDN in France whatever the catheter and the indication. This might include retrospective data for patient already treated with RDN in the past.
排除标准
- •RDN not proposed to the patient, patient opposing the collection and use of his/her data for research purposes.
结局指标
主要结局
Change in SBP measured by HBPM before and after RDN (1 year).
时间窗: before intervention and 1 year after intervention
Measurement of home blood pressure before and 1 year after RDN
次要结局
- Evaluate changes in office systolic blood pressure using the combination of SBP measured in HBPM and 24-hour-Automatic Blood Pressures Measurements (ABPM) before, 3 months, 6 months and 1 year, after DNR treatment.(before the DNR intervention and 3, 6, 12 months after DNR intervention)
- Evaluate the evolution at 3 months, 6 months, 1 year, of the drug burden in antihypertensive treatment, the percentage of patients having reached the blood pressure target and the win ratio.(Before intervention and 1-3, 6, 12 months after DNR intervention)
- Evaluate the development of renal artery stenosis before and 6 months, 1 year, after DNR.(before DNR, 6, 12 months after DNR)
- Evolution of creatinine levels before and 6 months, 1 year, after DNR.(before, 6 and 12 months after DNR)
- Evaluate the occurrence of other complications related to hypertension or to the procedure itself(from DNR intervention to 1 year follow up)
- Comparison of responders and non-responders to the procedure (24h ABPM systolic blood pressure decrease of 5 mmHg or more and/or the diminution of the medical burden by at least one therapeutic class without SBP increase compared to baseline).(inclusion, 1, 6, 12 months after the DNR procedure)
- Evaluate the performance of known predictors of response to renal denervation in our population.(from inclusion to 1 year follow up after the procedure)
- Describe the type of center performing the procedure, the context in which DNR is performed, patient characteristics and care pathways.(from inclusion to 1 year follow-up)