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Clinical Trials in Taiwan / NCT06676553
Recruiting Phase 4

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

NCT06676553 · tracked via the Priya Life Science Taiwan tracker
Phase
Phase 4
Started
2024-10-14
Last updated
2024-11-06

Condition(s) studied

Hypertension, UncontrolledHypertension, ResistantHypertension

Investigational drug(s) / intervention(s)

Radiofrequency ablation alone, re-denervation to main and/or branch renal arteryRadiofrequency ablation alone, no further renal denervation

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
National Taiwan University Hospital Taipei Taiwan Recruiting

More National Taiwan University Hospital trials in Taiwan

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06676553 on ClinicalTrials.gov ↗ ← All trials in Taiwan