Efficacy and Safety Comparison of Renal Sympathetic Denervation Combined With Aorticorenal Ganglion Ablation vs. Renal Sympathetic Denervation Alone for the Treatment of Hypertension: A Multicenter, Prospective, Proof-of-concept Cohort Trials.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The change of 24-hour ambulatory systolic blood pressure
研究概览
简要总结
The purpose of this prospective cohort proof-of-concept trial is to compare the efficacy and safety of renal sympathetic denervation (RSD) plus aorticorenal ganglion ablation versus RSD alone in the treatment of uncontrolled primary hypertension.
详细描述
Currently, renal sympathetic denervation (RSD) has become the "third pillar" of hypertension treatment, following lifestyle interventions and pharmacological therapy. However, it still faces challenges such as limited and unstable blood pressure-lowering effects. One of the key factors contributing to the poor efficacy of the procedure is inadequate renal sympathetic nerve ablation, which is influenced by the complex renal artery anatomy and nerve network distribution. From a neuroanatomical perspective, aorticorenal ganglion (ARG) is a crucial hub for sympathetic nerve projection to the kidneys. We hypothesize that on the basis of RSD, additional ablation of aorticorenal ganglion can enhance the BP-lowering effect in patients with uncontrolled primary hypertension. Therefore, we plan to design the first multicenter, prospective, cohort, proof-of-concept trial to compare the efficacy and safety of RSD plus ARG ablation (ARGA) versus RSD alone in the treatment of uncontrolled primary hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant female subjects;
- •18≤age≤70 years old;
- •Primary hypertension;
- •24-hour ASBP ≥130mmHg after standard anti-hypertensive drug therapy;
- •Arteries meet the criteria of catheter manipulation;
- •Patient understands the purpose of this study, and is willing to participate and sign the informed consent;
- •Patient is compliant and willing to complete clinical follow-up.
排除标准
- •Abdominal aorta and renal arteries are not eligibility for catheter manipulation: 1) Renal artery stenosis >50% or any renal artery aneurysms on either side 2) History of renal artery percutaneous transluminal angioplasty (PTA), including balloon angioplasty and stenting; 3) abdominal aortic dissection, ulceration, or stenosis.
- •eGFR <45ml/min/1.73m2 (MDRD formula)
- •Hospitalized within one year due to hypertensive crisis
- •Participated other clinical trials including both drug and medical device studies within 3 months enrollment
- •Female with pregnant or lactating, or having plans for pregnancy within 1 year
- •Patient with sleep apnea who needs chronic oxygen-breathing or mechanical ventilation support (for example, tracheostomy)
- •Patients previously or currently suffering from one of the following diseases: 1) Essential pulmonary arterial hypertension; 2) Type I diabetes; 3) Severe cardiac valvular stenosis; 4) History of myocardial infraction (MI), unstable angina, syncope or cerebrovascular accidents within half year; 5) History of primary aldosteronism, pheochromocytoma, aorta stenosis, hyperthyroidism or hyperparathyroidism; 6) Any disease conditions interfering the measurement of blood pressure (for instance, severe peripheral artery diseases, abdominal artery aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia and severe anemia); 7) Plans to have surgery or cardiovascular interventions within following 6 months; 8) Alcohol abuse or unknown drug dependence history; 9) Neuroticisms such as depression or anxiety disorders; 10) Non-compliant patients unable to finish the research per physician's requests.
研究组 & 干预措施
RSD group
High-frequency stimulation (HFS) guided radiofrequency ablation from accessible branches to the opening of the renal artery.
干预措施: Renal sympathetic denervation (Procedure)
RSD+ARGA group
High-frequency stimulation (HFS) guided radiofrequency ablation from accessible branches to the opening of the renal artery, as well as HFS-guided ARG ablation.
干预措施: Renal sympathetic denervation plus aorticorenal ganglion ablation (Procedure)
结局指标
主要结局
The change of 24-hour ambulatory systolic blood pressure
时间窗: From enrollment to the end of treatment at 3 months
次要结局
- The change of night-time ambulatory systolic blood pressure(From enrollment to the end of treatment at 3 months)
- The change of office systolic blood pressure(From enrollment to the end of treatment at 3 months)
- The change of drug burden index(From enrollment to the end of treatment at 3 months)
- The change of day-time ambulatory systolic blood pressure(From enrollment to the end of treatment at 3 months)
- Time of blood pressure controlling in target range(From enrollment to the end of treatment at 3 months)
研究者
Yuehui Yin
Director of the Department
The Second Affiliated Hospital of Chongqing Medical University