NCT04314557已完成不适用
Renal Arterial Denervation in Sympathetic Dysautonomia: RANSOM REGISTRY
St Carlos Hospital, Madrid, Spain1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年3月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in the descent of Systolic BP in orthostatism
研究概览
简要总结
The RANSOM registry is considered as a collection of data with the ultimate purpose of gathering information about the effect of renal denervation in patients of the investigator's center and evaluating the results within the usual clinical practice.
The general objective of the study is to evaluate the clinical results (blood pressure, quality of life and levels of catecholamines) as well as safety of renal sympathetic denervation in hypertensive patients, at least in treatment with an antihypertensive drug and with increased variability, considering as such a standard deviation> 10 mmHg for systolic BP and> 5 for diastolic BP of its blood pressure levels, measured by ABPM.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •All patients included in a prospective manner must sign an informed written consent and meet ALL of the following criteria that are typical of the procedure according to the protocol of our center:
- •Be considered adequate and eligible by the group of doctors responsible for the patient and by the multidisciplinary team of the study. Over 18 years, not pregnant.
- •Poorly controlled arterial hypertension, under treatment with at least one antihypertensive drug.
- •In addition, poorly controlled hypertension + increased variability, considering as such a standard deviation> 10 mmHg for systolic BP and> 5 for the diastolic BP of patient´s blood pressure levels, measured by ABPM.
- •Renal arteries anatomy suitable for the procedure, considered by CT, MRI, ultrasound or angiography.
- •Some criteria of dysautonomia, following the consensus of the American Autonomous Society (AAS) and the European Federation of Autonomous Societies (EFAS) of
- •or supine HTN. Defined as sBP ≥ 140 mmHg and / or dBP ≥ 90 mmHg, measured at least after 5 minutes of supine rest. Moderate forms (160-179 mmHg or dBP of 100-109 mmHg) or severe will preferably be included. (sBP≥ 180 mmHg and / or dBP ≥ 110 mmHg). Mild forms will be considered in conjunction with symptoms or other findings (ABPM) or nighttime HTN. Considered as such one that does not fall more than 10% compared to the daytime BP or even rises (riser). They will be considered in conjunction with symptoms or other findings (eg ABMP).
- •If the foregoing is not fulfilled, marked orthostatism (> 30 mmHG in sBP and / or> 10mmHG in dBP).
- •Life expectancy exceeding one year (not presenting terminal illness or any health condition for which a survival of less than one year is estimated).
排除标准
- •eGFR <30 mL / min / 1.73m
- •Monoxidin treatment.
- •Impossibility of informed consent by the patient or legal representative.
- •Impossibility for follow-up at least 1 year.
- •Do not fulfill inclusion criteria, assessed by the multidisciplinary team.
结局指标
主要结局
Change in the descent of Systolic BP in orthostatism
时间窗: 12 months
BP Variability decrease, any (yes/no).
次要结局
- Change in the descent of Systolic BP in orthostatism.(12 months)
- Measurement of quality of life and subjective perception of well-being.(12 months)
- Evolution of blood pressure control, average levels and variability(12 months)
- Safety end points(12 months)
研究者
IVAN J NUÑEZ GIL
Principal Investigator. Attending Physician. MD, PhD, FESC
St Carlos Hospital, Madrid, Spain
研究点 (1)
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