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

NCT06864962 | Withdrawn DMC

• 1 other identifier: RENATA-HTN
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Aorticorenal Ganglion; Renal Sympathetic Denervation; Autonomic Regulation; Hypertension

Outcome Measures

Primary Outcomes (1)

• The change of 24-hour ambulatory systolic blood pressure

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (5)

• 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 Outcomes (4)

• The primary adverse events

  From enrollment to the end of treatment at 3 months

• The score of SF-36

  From enrollment to the end of treatment at 3 months

• The score of GSRS

  From enrollment to the end of treatment at 3 months

Study Arms (2)

RSD group

ACTIVE COMPARATOR

High-frequency stimulation (HFS) guided radiofrequency ablation from accessible branches to the opening of the renal artery.

Procedure: Renal sympathetic denervation

RSD+ARGA group

EXPERIMENTAL

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

Interventions

Renal sympathetic denervation PROCEDURE

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.

RSD group

Renal sympathetic denervation plus aorticorenal ganglion ablation PROCEDURE

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.

RSD+ARGA group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and non-pregnant female subjects;
• ≤age≤70 years old;
• Primary hypertension;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• Shanghai Hongdian Medical CO., LTD: collaborator

Study Sites (2)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400072, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Nanan, 401336, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yuehui Yin, Professor

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)