RecruitingPhase 4NCT06676553

INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Trial (INFORM)

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

Sponsor

National Taiwan University Hospital

Enrollment

32 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Hypertension Hypertension, Uncontrolled Hypertension, Resistant

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a more precise method of renal denervation — a minimally invasive procedure that reduces overactive nerve signals to the kidneys — to treat high blood pressure that hasn't responded well to medication. The procedure uses real-time electrical feedback during the intervention to make it more accurate. **You may be eligible if...** - You have high blood pressure (hypertension) - You are willing to undergo the renal denervation procedure - Your blood pressure remains elevated despite taking blood pressure medications - Your 24-hour blood pressure readings confirm ongoing hypertension **You may NOT be eligible if...** - You have severely narrowed kidney arteries or abnormal kidney anatomy - You have significant kidney disease (low kidney function) - You have had a prior renal denervation procedure - You have certain heart conditions that prevent the procedure - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICERadiofrequency 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.

PROCEDURERadiofrequency 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