A Phase 4 interventional study of Radiofrequency ablation alone, re-denervation to main and/or branch renal artery and Radiofrequency ablation alone, no further renal denervation in Hypertension, Uncontrolled, Hypertension, Resistant and Hypertension, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment
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).
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 32 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →National Taiwan University Hospital is the lead sponsor of 2,608 studies on the registry; 573 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No further renal denervation after standard renal denervation procedure
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.
Device: Radiofrequency ablation alone, re-denervation to main and/or branch renal artery
No further renal denervation after standard renal denervation. The definition of non-suppressed is systolic blood pressure rise \>=20 mmHg compared to baseline.
Procedure: Radiofrequency ablation alone, no further renal denervation
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.
No further renal denervation after standard renal denervation even renal artery stimulation-induced systolic blood pressure rise \>= 20 mmHg
24-hour systolic blood pressure reduction (compared to baseline)
Time frame: 6 months following the index renal denervation
24-hour diastolic blood pressure reduction (compared to baseline)
Time frame: 6 months following the index renal denervation
Awake and asleep systolic/diastolic blood pressure and heart rate changes (compared to baseline)
Time frame: 6 months following the index renal denervation
Serum creatinine and estimated glomerular filtration rate changes
Time frame: 6 months following the index renal denervation
24-hour blood pressure changes based on branch artery constriction following renal artery stimulation
Time frame: 6 months following the index renal denervation
24-hour blood pressure reduction (compared to baseline)
Time frame: 1 year and 2 years following the index renal denervation
Plan to share: Yes — Under reasonable request and approved by the principle investigator, the information could be shared.
Supporting information: Study protocol, Clinical study report
Started Oct 2024 (actual). Primary completion is estimated for Oct 2026, 24 months after the start.
Of 159 non-industry phase 4 interventional studies under Hypertension, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 57. This study's planned 24 months is below that.
Counting every sponsor, half of 212 studies reached it within 32 months; a quarter within 16 and three quarters within 54.
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