Aorticorenal GanglionNCT06864962
Renal Sympathetic Denervation Combined With Aorticorenal Ganglion Ablation for Treatment of Hypertension
A study testing Renal sympathetic denervation and Renal sympathetic denervation plus aorticorenal ganglion ablation in people with Aorticorenal Ganglion and Renal Sympathetic Denervation, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aorticorenal Ganglion, Renal Sympathetic Denervation, Autonomic Regulation
- What is being tested?
- Renal sympathetic denervation and Renal sympathetic denervation plus aorticorenal ganglion ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400072
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Nanan, 401336
About this study
Official title: 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.
Read the 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.
- Being tested
- Renal sympathetic denervation, Renal sympathetic denervation plus aorticorenal ganglion ablation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal sympathetic denervationProcedure or surgery
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.
Renal sympathetic denervation plus aorticorenal ganglion ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| RSD group | Active comparator | High-frequency stimulation (HFS) guided radiofrequency ablation from accessible branches to the opening of the renal artery. Receives: 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. Receives: Procedure: Renal sympathetic denervation plus aorticorenal ganglion ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of 24-hour ambulatory systolic blood pressure
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (5)
The change of day-time ambulatory systolic blood pressure
Measured: From enrollment to the end of treatment at 3 months
The change of night-time ambulatory systolic blood pressure
Measured: From enrollment to the end of treatment at 3 months
The change of office systolic blood pressure
Measured: From enrollment to the end of treatment at 3 months
The change of drug burden index
Measured: From enrollment to the end of treatment at 3 months
Time of blood pressure controlling in target range
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: The hospital ethics review for this study is currently underway, and participant recruitment will commence once the approval is granted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorticorenal GanglionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Hongdian Medical CO., LTD
- Responsible party
- Principal investigator, Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Yuehui Yin, Professor, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864962
- Sponsor's protocol ID
- RENATA-HTN
- Status last verified
- May 2025
- First submitted
- 4 Mar 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06864962
- Acronym / sponsor ID
- RENATA-HTN
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The hospital ethics review for this study is currently underway, and participant recruitment will commence once the approval is granted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai Hongdian Medical CO., LTD
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSD group | Active comparator | Procedure: Renal sympathetic denervationHigh-frequency stimulation (HFS) guided radiofrequency ablation from accessible branches to the opening of the renal artery. |
| RSD+ARGA group | Experimental | Procedure: Renal sympathetic denervation plus aorticorenal ganglion ablationHigh-frequency stimulation (HFS) guided radiofrequency ablation from accessible branches to the opening of the renal artery, as well as HFS-guided ARG ablation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal sympathetic denervationUnder 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 or surgery | RSD group |
| Renal sympathetic denervation plus aorticorenal ganglion ablationFollowing 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. | Procedure or surgery | RSD+ARGA group |
Primary outcome
The change of 24-hour ambulatory systolic blood pressure
Time frame: From enrollment to the end of treatment at 3 months
5 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuehui Yin, Professor principal investigator
The Second Affiliated Hospital of Chongqing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal sympathetic denervation and Renal sympathetic denervation plus aorticorenal ganglion ablation in people with Aorticorenal Ganglion and Renal Sympathetic Denervation, run by The Second Affiliated Hospital of Chongqing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of 24-hour ambulatory systolic blood pressure (time frame: From enrollment to the end of treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.