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

ClinicalTrials.gov IDNCT06676553

PhasePHASE4

Enrollment32

SponsorNational Taiwan University Hospital

Age18 Years

SexALL

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Conditions studied

Hypertension, Uncontrolled, Hypertension, Resistant, Hypertension

About this study

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.

Interventions

Device: 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.
Procedure: 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

Primary outcomes

24-hour systolic blood pressure reduction (compared to baseline) (6 months following the index renal denervation)

Eligibility information

Inclusion Criteria: * Patients with hypertension and are willing to undergo renal denervation. * Patients are treated with antihypertensive medications, or with an office systolic blood pressure (SBP) \>140 mm Hg or diastolic blood pressure (DBP) \>90 mm Hg, and 24-hour SBP of \>130 mmHg or DBP \>80 mm Hg, irrespective of antihypertensive treatment. Exclusion Criteria: * An unsuitable renal artery anatomy for renal denervation, assessed by computed tomographic angiography (main renal artery lumen diameter \<3 mm or a total length \<20 mm). * Secondary hypertension, including hyperaldosteronism, pheochromocytoma, and renal artery stenosis (\>50% stenosis in one or both arteries).

Study locations

National Taiwan University Hospital, Taipei, 100225 Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.