ACTRN12613000360718招募中未知
For Adults with Uncontrolled Hypertension, is Neuromodulation an Effective Adjunct to Pharmaceutical Intervention for Reduction in Systolic Blood Pressure.
Valencia Technologies, Corp.0 个研究点目标入组 102 人开始时间: 2013年4月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1.Individual has a systolic blood pressure measured at greater than or equal to 140mmHg in the most recent medical history and which is confirmed with in-office blood pressure measured at both an initial screening and baseline screening visit and also with a 24 hour Ambulatory blood pressure, despite adhering to a stable anti-hypertensive drug regimen for a minimum of two weeks prior to enrollment of three or more anti- hypertensive medications including a diuretic
- •2.Individual has a systolic blood pressure measured at greater than or equal to 160mmHg in the most recent medical history and which is confirmed with in-office blood pressure measured at both an initial screening and baseline screening visit and also with a 24 hour Ambulatory blood pressure, despite adhering to a stable anti-hypertensive drug regimen for a minimum of two weeks prior to enrollment of two or more anti- hypertensive medications and has documented allergy to or intolerance of additional antihypertensive medications.
排除标准
- •1.Individual in whom medications are expected to change during the next 12 months
- •2.Individual does not agree to have all study procedures performed, and is not competent and willing to provide written, informed consent to participate in this clinical study.
- •3.Individual has type 1 diabetes mellitus.
- •4.Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six months of the screening visit.
- •5.Individual has a scheduled or planned surgery, cardiovascular intervention, or dialysis in the next six months.
- •6.Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- •7.Individual has any serious medical condition with a prognosis of <2 years.
- •8.Individual has significant anemia (hemoglobin <100g/L), thrombocytopenia (platelets <100x109/L) or a severe bleeding disorder eg. hemophilia.
- •9.Individual has secondary hypertension (other than associated with obstructive sleep apnea)
- •10.Individual is pregnant, nursing or planning to be pregnant.
- •11.Individual has known or suspected history of medication non-compliance
- •12.Individual has 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.
- •13.Patient has undergone renal denervation.
- •14.Individual has severe renal dysfunction (CKD V, eGFR <15)
- •15.Individual has another implantable stimulation device including a cardiac pacemaker, ICD, spinal cord stimulator, brain stimulator, vagus nerve stimulator, peripheral nerve stimulator, or cochlear implant.
- •16.Patient is scheduled to have an MRI.
- •17.Individual is currently enrolled in another investigational drug or device trial that has not reached its primary endpoint.
研究者
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