An interventional study of Renal sympathetic denervation and Renal sympathetic denervation plus aorticorenal ganglion ablation in Aorticorenal Ganglion, Renal Sympathetic Denervation and Autonomic Regulation, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Withdrawn at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Not applicable, Interventional, and Treatment
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.
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.
136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.
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Exclusion Criteria:
High-frequency stimulation (HFS) guided radiofrequency ablation from accessible branches to the opening of the renal artery.
Procedure: Renal sympathetic denervation
High-frequency stimulation (HFS) guided radiofrequency ablation from accessible branches to the opening of the renal artery, as well as HFS-guided ARG ablation.
Procedure: Renal sympathetic denervation plus aorticorenal ganglion ablation
Under the guidance of the 3-dimensional navigation system, HFS was performed from the accessible branches to the proximal (the ostium of renal artery) segments of the bilateral renal arteries, and the target ablation sites were identified by HFS-induced SBP elevation \>5mmHg, and radiofrequency ablations were performed with a power setting of 8 to 12 Watts and a duration of 90 seconds. The endpoint of RSD was defined as the elimination or bluntness of HFS-induced SBP elevation response (≤5mmHg). If this was not achieved, ablation was repeated until the desired response was attained.
Following RSD, HFS was performed in the the junction area of abdominal aorta and renal arteries to recognize ARG. Radiofrequency ablations were performed with a power setting of 12 to 20 Watts and a duration of 90 seconds. The endpoint of ablation was defined as the elimination or bluntness of HFS-induced SBP elevation response (≤5mmHg). If this was not achieved, ablation was repeated until the desired response was attained.
The change of 24-hour ambulatory systolic blood pressure
Time frame: From enrollment to the end of treatment at 3 months
The change of day-time ambulatory systolic blood pressure
Time frame: From enrollment to the end of treatment at 3 months
The change of night-time ambulatory systolic blood pressure
Time frame: From enrollment to the end of treatment at 3 months
The change of office systolic blood pressure
Time frame: From enrollment to the end of treatment at 3 months
The change of drug burden index
Time frame: From enrollment to the end of treatment at 3 months
Time of blood pressure controlling in target range
Time frame: From enrollment to the end of treatment at 3 months
The primary adverse events
The primary adverse events was defined as the composite outcomes including all-cause mortality, end-stage renal disease, embolic events with end-organ damage, arterial perforation/dissection requiring intervention, hypertensive crisis requring hospitalization, new-onset renal stenosis (\>70%)
Time frame: From enrollment to the end of treatment at 3 months
The score of SF-36
SF-36: The Short-From-36 Health Survey
Time frame: From enrollment to the end of treatment at 3 months
The score of GSRS
GSRS: gastrointestinal symptom rating scale
Time frame: From enrollment to the end of treatment at 3 months
The score of sexual function scale
International Index of Erectile Function for male; Femal Sexual Function Index for female.
Time frame: From enrollment to the end of treatment at 3 months
Plan to share: No
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This study is withdrawn, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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The Second Affiliated Hospital of Chongqing Medical University