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| ID | Type | Description | Link |
|---|---|---|---|
| ERP-2023-13518 | Other Grant/Funding Number | Medtronic |
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| Name | Class |
|---|---|
| Smart Health Technology Research and Development Center, National Taiwan University | UNKNOWN |
| Medtronic | INDUSTRY |
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Our previous study (Huang HC, Pan HY, Wang TD, Circ Cardiovasc Interv 2023;16:e012779) demonstrated that when renal artery stimulation continues to trigger systolic blood pressure increases (>=20 mmHg increase compared to baseline) after the initial procedure, patients show poor blood pressure reduction 6 months following renal denervation. Based on this finding, we designed a proof-of-concept trial comparing two approaches: a guided strategy versus conventional renal denervation. In the guided strategy, we perform additional ablations of main and/or branch renal arteries if immediate post-procedure stimulation still elevates systolic blood pressure (>=20 mmHg increase compared to baseline). The conventional approach involves no repeat procedures. This trial aims to determine whether the guided strategy leads to better clinical outcomes, measured by 6-month ambulatory blood pressure changes, and to establish the value of using intraprocedural feedback to assess and guide renal denervation treatment.
After RDN completed, renal artery stimulation will be repeated immediately. The maximal RAS-induced SBP changes will be recorded. All BP readings are the average of 8 consecutive beats by default (Siemens, Germany), which could minimize the inadvertent BP fluctuations by movements and respiration (8 beats could encompass at least one respiratory cycle). The branch renal artery constriction since the start of RAS till 3 minutes after its discontinuation will be recorded. The body reaction during RAS will be recorded (0, no response; 1, mild (voice) response; 2. limited movement; 3. significant movement).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Renal artery stimulation-induced systolic blood pressure rise suppressed (<20 mmHg) | No Intervention | No further renal denervation after standard renal denervation procedure | |
| B: Re-denervation if renal artery stimulation-induced systolic blood pressure rise not suppressed | Active Comparator | Another round of renal denervation (main renal artery for positive proximal stimulation; branch artery for positive distal stimulation) after standard renal denervation. The definition of non-suppressed is systolic blood pressure rise >=20 mmHg compared to baseline. |
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| C: Control if renal artery stimulation-induced systolic blood pressure rise not suppressed | Placebo Comparator | No further renal denervation after standard renal denervation. The definition of non-suppressed is systolic blood pressure rise >=20 mmHg compared to baseline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation alone, re-denervation to main and/or branch renal artery | Device | Re-denervation according to the site where renal artery stimulation can induce systolic blood pressure rise of >= 20 mmHg. Main renal artery denervation if proximal main renal artery stimulation positive, while branch renal artery denervation if distal main renal artery stimulation positive. |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour systolic blood pressure reduction (compared to baseline) | 6 months following the index renal denervation |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour diastolic blood pressure reduction (compared to baseline) | 6 months following the index renal denervation | |
| Awake and asleep systolic/diastolic blood pressure and heart rate changes (compared to baseline) | 6 months following the index renal denervation |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour blood pressure changes based on branch artery constriction following renal artery stimulation | 6 months following the index renal denervation | |
| 24-hour blood pressure reduction (compared to baseline) | 1 year and 2 years following the index renal denervation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tzung-Dau Wang, MD, PhD | Contact | 886-972651070 | tdwang@ntu.edu.tw | |
| Ya-Chun Chen, BS | Contact | 886-2-23123456 | 265877 | yachun0411@gmai.com |
| Name | Affiliation | Role |
|---|---|---|
| Tzung-Dau Wang, MD, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100225 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36802802 | Result | Huang HC, Pan HY, Wang TD. Renal Nerve Stimulation Predicted Blood Pressure-Lowering Responses to Percutaneous Renal Denervation. Circ Cardiovasc Interv. 2023 Feb;16(2):e012779. doi: 10.1161/CIRCINTERVENTIONS.122.012779. Epub 2023 Feb 21. No abstract available. |
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Under reasonable request and approved by the principle investigator, the information could be shared.
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| Radiofrequency ablation alone, no further renal denervation | Procedure | No further renal denervation after standard renal denervation even renal artery stimulation-induced systolic blood pressure rise >= 20 mmHg |
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| Serum creatinine and estimated glomerular filtration rate changes | 6 months following the index renal denervation |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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