Not provided
Not provided
Not provided
Not provided
Not provided
The hospital ethics review for this study is currently underway, and participant recruitment will commence once the approval is granted.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Hongdian Medical CO., LTD | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSD group | Active Comparator | High-frequency stimulation (HFS) guided radiofrequency ablation from accessible branches to the opening of the renal artery. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of 24-hour ambulatory systolic blood pressure | From enrollment to the end of treatment at 3 months |
| Measure | Description | 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yuehui Yin, Professor | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400072 | China | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 |
| 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 |
| The Second Affiliated Hospital of Chongqing Medical University |
| Chongqing |
| Nanan |
| 401336 |
| China |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided