Renal Pelvic Denervation for High Blood Pressure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with high blood pressure that remains difficult to control despite taking two medications. The treatment employs a technique called renal pelvic denervation, which targets specific nerves in the kidneys with energy to help lower blood pressure. Participants will be divided into two groups: one will receive the actual treatment, while the other will undergo a similar procedure without the active treatment. Suitable candidates are those already on two blood pressure medications but still experiencing high readings.
As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.
Will I have to stop taking my current medications?
Participants must continue taking their current two anti-hypertensive medications without changes until after the 2-month primary endpoint of the trial.
What prior data suggests that the RPDTM renal denervation system is safe for hypertensive patients?
Research has shown that renal pelvic denervation (RPD) offers a safe option for people whose high blood pressure doesn't improve with medication. In one study, patients who underwent this procedure experienced a significant and lasting drop in blood pressure for at least a year, indicating its long-term safety. Additionally, a trial found that all patients treated with RPD experienced a notable decrease in blood pressure. These findings strongly suggest that the RPD system is well-tolerated by patients and can safely help manage high blood pressure.12345
Why are researchers excited about this trial?
Renal Pelvic Denervation is unique because it targets hypertension by using the Verve RPD™ system to deliver RF energy directly to the walls of the renal pelvis via the urinary tract. This method is different from standard treatments like medications such as ACE inhibitors or beta-blockers that work by altering hormone levels or heart rate. Researchers are excited about this technique because it offers a novel approach by potentially reducing nerve activity directly in the kidneys, which could lead to more effective blood pressure control with fewer systemic side effects. Additionally, the use of a natural orifice for delivery minimizes the invasiveness, offering a promising alternative to more traditional surgical procedures.
What evidence suggests that the RPDTM system is effective for high blood pressure?
Research has shown that renal pelvic denervation (RPD), which participants in this trial may receive, can effectively lower blood pressure in patients whose high blood pressure doesn't respond to medication. In one study, all patients who underwent this procedure experienced a significant drop in blood pressure. Another study found that RPD reduced systolic blood pressure by about 3.9 mmHg compared to a sham procedure. The blood pressure-lowering effects of RPD are not only significant but also last for at least a year. These findings suggest that RPD could be a promising option for managing stubborn high blood pressure.12356
Are You a Good Fit for This Trial?
This trial is for patients with high blood pressure not controlled by two anti-hypertensive medications. Participants must have been on a stable medication regimen for at least 30 days, with specific blood pressure ranges (daytime SBP <170 and DBP <105 mmHg; mean daytime SBP ≥135 mmHg; office systolic SBP ≥140 mmHg and <180).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo renal pelvic denervation using the Verve RPD™ system or a sham procedure
Follow-up
Participants are monitored for safety and effectiveness, including blood pressure and renal function assessments
Open-label extension (optional)
Sham treated subjects may receive open-label therapy if they meet the original inclusion/exclusion criteria
What Are the Treatments Tested in This Trial?
Interventions
- Renal Pelvic Denervation
Trial Overview
The trial tests the RPDTM renal denervation system's safety and effectiveness. It involves placing a device into the renal pelvis to deliver radiofrequency energy that ablates nerves potentially responsible for high blood pressure.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The Verve RPD™ system is used to perform renal pelvic denervation via the urinary collecting system for the treatment of hypertension. The system does so through the delivery of RF energy to the walls of the renal pelvis - delivered via natural orifice through the urinary tract. During the course of the study, patients will be on active medical therapy for their hypertension.
Sham procedure will include all steps employed in the renal pelvis denervation with exception of activation of the RPD™ Device. Sham procedure includes advancing guidewire, cystoscope and sheath to position within the renal pelvis, then deploying the RPD™ Device into the renal pelvis (within each kidney), keeping the device in place for 2 minutes (within each kidney) to simulate activation, and then withdrawing the device and sheath. During the course of the study, sham patients will be on active medical therapy for their hypertension.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Verve Medical, Inc
Lead Sponsor
Medical Labs Memphis - MLM
Collaborator
RQM+
Industry Sponsor
Dabl Ltd
Collaborator
Citations
Durability of the Blood Pressure Effects of Renal Pelvic ...
These findings provide evidence that the significant blood pressure-lowering effects of renal pelvic denervation are durable and safe for at least 1 year.
Transurethral Renal Pelvic Denervation: A Feasibility Trial ...
In patients with uncontrolled hypertension despite medications, this procedure was effective in significantly reducing blood pressure.
NCT07005050 | Renal Pelvic Denervation Pilot Trial
Several clinical trials demonstrate the potential utility of renal denervation to improve blood pressure control as an adjunct to medications, yet the results ...
4.
eurointervention.pcronline.com
eurointervention.pcronline.com/article/renal-denervation-in-the-management-of-hypertensionRenal denervation in the management of hypertension
Compared with sham, RDN lowered 24-hour and office systolic BP after 3 months by 3.9 mmHg (95% Bayesian credible interval [BCI]: 1.6 to 6.2) and ...
Verve Medical's Data Published From Feasibility Trial for ...
The findings included a therapeutically significant blood pressure (BP) reduction for 100% of treated patients with uncontrolled hypertension.
Verve Medical's Data Published From Feasibility Trial for ...
The findings included a therapeutically significant blood pressure (BP) reduction for 100% of treated patients with uncontrolled hypertension.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.