NCT06864962

Renal Sympathetic Denervation Combined With Aorticorenal Ganglion Ablation for Treatment of Hypertension

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.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aorticorenal Ganglion
• Renal Sympathetic Denervation
• Autonomic Regulation
• Hypertension

Interventions

Type	Name	Description
PROCEDURE	Renal sympathetic denervation	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.
PROCEDURE	Renal sympathetic denervation plus aorticorenal ganglion ablation	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-03-07
• Last updated: 2025-05-14

Locations

2 sites across 1 country: China