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INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Trial (INFORM)
Sponsor: National Taiwan University Hospital
Summary
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.
Official title: INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Proof-of-concept Trial to Assess Whether Renal Denervation Guided by Renal Artery Stimulation Outperforms Conventional Renal Denervation in 6-month Ambulatory Blood Pressure Reductions
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2024-10-14
Completion Date
2028-06-30
Last Updated
2024-11-06
Healthy Volunteers
No
Interventions
Radiofrequency ablation alone, re-denervation to main and/or branch renal artery
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.
Radiofrequency ablation alone, no further renal denervation
No further renal denervation after standard renal denervation even renal artery stimulation-induced systolic blood pressure rise \>= 20 mmHg
Locations (1)
National Taiwan University Hospital
Taipei, Taiwan