Denervation of the REnal Artery in Metabolic Syndrome (DREAMS)
Sympathetic Denervation of the Renal Artery for the Treatment of Obesity-related Hypertension and Insulin Resistance
The current prevalence of hypertension as part of the metabolic syndrome is substantial and is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a common and key factor in disease states as obesity-related hypertension (ORH). The renal sympathetic nerves are a major contributor to the complex pathophysiology of this elevated SNS activity. Percutaneous renal denervation (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity.
This current study is an observational feasibility study, with the aim to investigate the effect of renal denervation on changes in insulin resistance and blood pressure in patients with obesity related hypertension. The investigators will study different variables: a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory.
Hypothesis
- The investigators hypothesize that renal denervation has a beneficial effect on insulin resistance.
- The investigators hypothesize that there will be no complications related to the device or procedure.
研究概览
详细说明
Objectives: The objectives of this study are: to compare changes in insulin resistance in patients with ORH after RDN; to evaluate the safety of PRDN in this patient group; to compare changes in blood pressure, laboratory parameters, arterial stiffness and SNS-activity after PRDN.
Study design: Prospective observational feasibility-study.
Study population: Patients with a high fasting glucose (fasting serum glucose ≥5.6 mmol/L(100 mg/dL)) and with an ambulatory systolic blood pressure >130mmHg.
Major endpoints: The effect of RDN on: insulin resistance, blood pressure and major adverse events.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Utrecht、荷兰
- UMC Utrecht
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients should have a high fasting glucose (fasting serum glucose ≥5.6 mmol/L (≥100 mg/dL)), without the use of antidiabetic drugs at the time of inclusion AND should have a 24 hour ambulatory SBP >130 mmHg, without the use of antihypertensive drugs at the time of inclusion.
- Patients should fulfil one or more other criteria to meet the definition of the metabolic syndrome.
- Individual understands the study procedures, alternative treatments available, risks involved with the study and voluntarily agrees to participate by giving informed consent.
- Individual is over 18 years of age on the day of signing informed consent.
Exclusion Criteria:
- SBP >180 mmHg and/or DBP >110 mmHg during one or more screening measurements.
- 24-hour ambulatory SBP >170 mmHg and/or 24-hour ambulatory DBP >100 mmHg at time of inclusion.
- Individual is treated with more than one type of antihypertensive medication at time of inclusion.
- Individual is treated with more than one type of drug for diabetes mellitus 2 at time of inclusion and/or the medication for DM type 2 can not be stopped.
- Individual has a treatable secondary cause of hypertension.
- Individual has renal artery anatomy that is ineligible for treatment.
- Individual has an estimated glomerular filtration rate (eGFR) of <45mL/min/1.73m2, using the MDRD calculation.
- Individual has type 1 diabetes mellitus.
- Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Individual has scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- Individual has hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous.
- Individual has an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for RF energy delivery.
- Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, or significant anaemia).
- Individual is pregnant, nursing or planning to be pregnant.
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Individual is currently enrolled in another investigational drug or device trial.
Individual is currently being treated with any of the following medications:
- Drugs that cause salt retention (e.g., systemic corticosteroids and fludrocortisone)
- Acenocoumarol or phenprocoumon that cannot be temporarily stopped for the procedure.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:去肾神经
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percutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Difference in Insulin resistance before and 12 months after renal denervation
大体时间:T=0, T=6 months, and t=12 months
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To investigate the influence of percutaneous renal sympathetic denervation on insulin resistance.
Hereby evaluating an Oral Glucose Tolerance Test before and after renal denervation
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T=0, T=6 months, and t=12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Difference in blood pressure before and after renal denervation
大体时间:t=0, t=6 months, and t=12 months
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t=0, t=6 months, and t=12 months
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Safety
大体时间:one year
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Major adverse events, characterized by myocardial infarction, cerebrovascular accident or all-cause mortality.
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one year
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Fasting glucose before and after renal denervation
大体时间:t=0 and t=12 months
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t=0 and t=12 months
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Change in Muscle sympathetic nerve activity (MSNA)after renal denervation
大体时间:t=0 and t=6 months
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t=0 and t=6 months
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合作者和调查者
赞助
调查人员
- 首席研究员:Michiel Voskuil, MD, PhD、UMC Utrecht
- 首席研究员:Willemien Verloop, MD、UMC Utrecht
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Renal denervation的临床试验
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Hippocration General HospitalReCor Medical, Inc.招聘中