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

Recruiting · NCT06676553 · Interventional (participants receive a specific treatment) · Lead sponsor: National Taiwan University Hospital

View the official record on ClinicalTrials.gov →

Hypertension

Interventions studied

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

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 4

Study type

Interventional (participants receive a specific treatment)

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).

Where it is running

1 location listed.

National Taiwan University Hospital - Taipei, Taiwan

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →