Optimizing renal denervation for uncontrolled hypertension
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
This study is testing if a new method of renal denervation that uses real-time feedback can help people with high blood pressure more effectively than the standard approach.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06676553 on ClinicalTrials.gov |
What this trial studies
This trial compares two approaches to renal denervation for patients with uncontrolled hypertension: a guided strategy that involves additional ablations based on real-time feedback from renal artery stimulation, and a conventional approach that does not include repeat procedures. The study aims to determine if the guided strategy leads to better blood pressure outcomes after six months. Patients will undergo renal artery stimulation and radiofrequency ablation using a specialized catheter, with careful monitoring of blood pressure responses throughout the procedure.
Who should consider this trial
Good fit: Ideal candidates are patients with uncontrolled hypertension who are willing to undergo renal denervation and meet specific blood pressure criteria.
Not a fit: Patients with unsuitable renal artery anatomy or secondary hypertension conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve blood pressure control in patients with resistant hypertension.
How similar studies have performed: Previous studies have shown promising results with renal denervation, but this guided approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Tzung-Dau Wang, MD, PhD — National Taiwan University Hospital
- Study coordinator: Tzung-Dau Wang, MD, PhD
- Email: tdwang@ntu.edu.tw
- Phone: 886-972651070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.