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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Aorticorenal Ganglion; Renal Sympathetic Denervation; Autonomic Regulation
• Intervention / Treatment: Procedure: Renal sympathetic denervation; Procedure: Renal sympathetic denervation plus aorticorenal ganglion ablation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400072
      • The Second Affiliated Hospital of Chongqing Medical University
  • Nanan
    • Chongqing, Nanan, China, 401336
      • The Second Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RSD group; High-frequency stimulation (HFS) guided radiofrequency ablation from accessible branches to the opening of the renal artery.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of 24-hour ambulatory systolic blood pressure	From enrollment to the end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The change of day-time ambulatory systolic blood pressure	From enrollment to the end of treatment at 3 months
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
Time of blood pressure controlling in target range	From enrollment to the end of treatment at 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%)	From enrollment to the end of treatment at 3 months
The score of SF-36	SF-36: The Short-From-36 Health Survey	From enrollment to the end of treatment at 3 months
The score of GSRS	GSRS: gastrointestinal symptom rating scale	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.	From enrollment to the end of treatment at 3 months

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Collaborators: Shanghai Hongdian Medical CO., LTD
• Investigators: Principal Investigator: Yuehui Yin, Professor, The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 10, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Connective Tissue Diseases; Cysts; Mucinoses; Hypertension; Ganglion Cysts; Synovial Cyst
• Other Study ID Numbers: RENATA-HTN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No