Actively Recruiting
INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Trial (INFORM)
Led by National Taiwan University Hospital · Updated on 2024-11-06
32
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
S
Smart Health Technology Research and Development Center, National Taiwan University
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Trial (INFORM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hypertension willing to undergo renal denervation
- Treated with antihypertensive medications or
- Office systolic blood pressure over 140 mm Hg or diastolic blood pressure over 90 mm Hg
- 24-hour systolic blood pressure over 130 mm Hg or diastolic blood pressure over 80 mm Hg regardless of treatment
You will not qualify if you...
- Unsuitable renal artery anatomy for denervation (main renal artery diameter less than 3 mm or length less than 20 mm)
- Secondary hypertension including hyperaldosteronism, pheochromocytoma, or renal artery stenosis over 50%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
Research Team
T
Tzung-Dau Wang, MD, PhD
CONTACT
Y
Ya-Chun Chen, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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