Clinical trial NCT06864962: Renal Sympathetic Denervation Combined With Aorticorenal Ganglion Ablation for Treatment of Hypertension
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aorticorenal Ganglion
Renal Sympathetic Denervation
Autonomic Regulation
Hypertension
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai Hongdian Medical CO., LTD
First posted: 2025-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The change of 24-hour ambulatory systolic blood pressure
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
measure: The change of day-time ambulatory systolic blood pressure
timeFrame: From enrollment to the end of treatment at 3 months
measure: The change of night-time ambulatory systolic blood pressure
timeFrame: From enrollment to the end of treatment at 3 months
measure: The change of office systolic blood pressure
timeFrame: From enrollment to the end of treatment at 3 months
measure: The change of drug burden index
timeFrame: From enrollment to the end of treatment at 3 months
measure: Time of blood pressure controlling in target range
timeFrame: From enrollment to the end of treatment at 3 months
Other outcomes:
measure: The primary adverse events
timeFrame: From enrollment to the end of treatment at 3 months
measure: The score of SF-36
timeFrame: From enrollment to the end of treatment at 3 months
measure: The score of GSRS
timeFrame: From enrollment to the end of treatment at 3 months
measure: The score of sexual function scale
timeFrame: From enrollment to the end of treatment at 3 months
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Nanan
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Yuehui Yin, Professor
role: PRINCIPAL_INVESTIGATOR
References: