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

Last updated: May 10, 2025
Sponsor: The Second Affiliated Hospital of Chongqing Medical University
Overall Status: Trial Not Available

Phase

N/A

Condition

Stress

Vascular Diseases

Autonomic Nervous System

Treatment

Renal sympathetic denervation plus aorticorenal ganglion ablation

Renal sympathetic denervation

Clinical Study ID

NCT06864962
RENATA-HTN
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andsign the informed consent;

  • Patient is compliant and willing to complete clinical follow-up.

Exclusion

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) Historyof renal artery percutaneous transluminal angioplasty (PTA), including balloonangioplasty 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 studieswithin 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 mechanicalventilation 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 cardiacvalvular stenosis; 4) History of myocardial infraction (MI), unstable angina,syncope or cerebrovascular accidents within half year; 5) History of primaryaldosteronism, pheochromocytoma, aorta stenosis, hyperthyroidism orhyperparathyroidism; 6) Any disease conditions interfering the measurement of bloodpressure (for instance, severe peripheral artery diseases, abdominal arteryaneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia and severeanemia); 7) Plans to have surgery or cardiovascular interventions within following 6months; 8) Alcohol abuse or unknown drug dependence history; 9) Neuroticisms such asdepression or anxiety disorders; 10) Non-compliant patients unable to finish theresearch per physician's requests.

Study Design

Treatment Group(s): 2
Primary Treatment: Renal sympathetic denervation plus aorticorenal ganglion ablation
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400072
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.