Renal nerve stimulation for patients with uncontrolled hypertension undergoing renal denervation
National Tawan University Hospital
PHASE4 · National Taiwan University Hospital · NCT05421767
This study is testing if adding renal nerve stimulation can help lower blood pressure in people with hard-to-control hypertension who are also getting renal denervation.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05421767 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of renal nerve stimulation (RNS) on blood pressure changes in patients with uncontrolled hypertension who are undergoing renal denervation (RDN). It aims to determine if a specific cutoff value of RNS-induced systolic blood pressure change can serve as a useful clinical endpoint for RDN therapy. The study will assess the hypothesis that intense RDN can enhance the effectiveness of the procedure. By evaluating the relationship between RNS and blood pressure response, the research seeks to improve treatment outcomes for resistant hypertension.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20-80 with uncontrolled hypertension and a glomerular filtration rate above 45 mL/min.
Not a fit: Patients with unsuitable renal artery anatomy or untreated secondary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of resistant hypertension, improving patient outcomes and quality of life.
How similar studies have performed: Previous studies have shown promising results with renal denervation techniques, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with hypertension (HTN), including 1. 24-hour ambulatory blood pressure \>130/ 80 mmHg 2. Age 20-80 years 3. Glomerular filtration rate \>45 mL/min Exclusion Criteria: 1. Unsuitable renal artery anatomy computed tomographic angiography (main renal artery lumen diameter ≤3 mm or a total length \<20 mm of the main arteries). 2. untreated secondary HTN, including hyperaldosteronism, pheochromocytoma, renal artery stenosis(\>50% stenosis)
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
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.
Conditions: Hypertension, renal nerve stimulation, renal nerve denervation, Sympathetic nerve activity