ACTRN12615000203550招募中2 期
A phase II randomised, controlled pilot study to evaluate the safety and feasibility of renal denervation in heart failure patients on maximal medical treatment
Dr Suku Thambar0 个研究点目标入组 20 人开始时间: 2015年3月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Able to comprehend requirements and provide consent.
- •2. Males or females greater than or equal to 18years.
- •3. Established congestive heart failure with NYHA Class II-III
- •4. Left Ventricular Ejection Fraction (LVEF) less than or equal to 35% on echocardiography.
- •5. Adequate renal function with estimated GFR greater than or equal to 30 mL/min.
- •6. Optimal stable medical therapy for heart failure for at
- •least 3 months prior to study entry as per ACCF/AHA
- •guidelines.
排除标准
- •1. Renal artery abnormalities (i.e. too small, presence of significant stenosis, prior angioplasty procedure, multiple main renal arteries).
- •2. Single functioning kidney.
- •3. End Stage Renal Disease requiring haemo-dialysis or
- •renal transplant.
- •4. Unstable vascular syndromes, such as myocardial
- •infarction, unstable angina pectoris or cerebro-vascular
- •accident, within 3 months.
- •5. Systolic blood pressure less than 100mmHg.
- •6. Haemodynamically significant valvular heart disease.
- •7. Pregnant, nursing or planning on becoming pregnant
- •during the course of the study.
- •8. Enrolled in, or intend to participate in, another
- •investigational drug or device trial.
- •9. Any concurrent disease or condition that, in the opinion
- •of the investigator, would make the subject unsuitable
- •for participation in the study.
研究者
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