Renal and Splanchnic Nerve Denervation for High Blood Pressure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to lower high blood pressure and improve blood sugar levels in individuals with resistant hypertension and type 2 diabetes. The procedure, called renal nerve denervation, uses a catheter to deliver radiofrequency energy to specific nerves. The trial includes two groups: one group will receive treatment only on the renal nerves, while the other will receive treatment on both renal and splanchnic (abdominal area) nerves. Suitable candidates have had type 2 diabetes for at least five years and take at least three blood pressure medications without improvement. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for managing resistant hypertension and type 2 diabetes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it requires that you have a stable drug regimen of at least 3 antihypertensive medications with no changes for 2 weeks before enrollment.
What prior data suggests that this method is safe for improving blood pressure and glycemic control?
Research has shown that renal denervation (RDN) is generally safe for individuals with hard-to-control high blood pressure. Studies have found no major issues with kidney function after the procedure, even in those with early kidney disease. RDN is approved for treating resistant hypertension, indicating its safety for this condition.
Splanchnic nerve denervation is often performed alongside renal denervation to further reduce blood pressure. This combined method uses radiofrequency ablation, a technique that applies heat to target specific nerves. Studies have not reported any significant side effects with this approach.
Overall, both procedures are well-tolerated, with most individuals experiencing only mild side effects, if any. It is important to consult a healthcare provider for personal advice.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for high blood pressure, which typically involve medications like ACE inhibitors or beta-blockers, renal and splanchnic nerve denervation offers a unique approach. This method uses radiofrequency ablation to target and disrupt nerves in the renal arteries and splanchnic region, which play a role in blood pressure regulation. Researchers are excited because this could provide a non-drug option for patients who don't respond well to medication, potentially leading to more consistent blood pressure control. Plus, the use of catheter-based techniques offers a minimally invasive alternative to surgery, which could mean quicker recovery times and fewer side effects for patients.
What evidence suggests that this trial's treatments could be effective for resistant hypertension and type 2 diabetes?
This trial will compare two approaches: renal denervation alone and combined renal and splanchnic nerve denervation. Studies have shown that renal denervation effectively lowers blood pressure in people with resistant hypertension. For example, one study found that this treatment reduced blood pressure measured in a doctor's office by 6.5 mmHg after three months. Another study reported a 12.2 mmHg reduction in daytime blood pressure six months after the procedure. This technique uses radiofrequency energy to disrupt nerve activity in the kidney arteries, helping to relax blood vessels and lower blood pressure. Research also suggests this method is safe and may improve blood sugar control in patients with type 2 diabetes.13678
Who Is on the Research Team?
Jose Wiley, MD, MPH, FACC, FACP, FSCAI
Principal Investigator
Tulane University
Are You a Good Fit for This Trial?
The RESPLASH Study is for individuals with resistant hypertension (high blood pressure that's tough to control) and type 2 diabetes. Participants should not have had previous denervation procedures or conditions that might interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo catheter-based endovascular denervation (CDN) of renal arteries, with or without splanchnic nerve denervation
Follow-up
Participants are monitored for changes in blood pressure and glycemic control at 1, 3, and 6 months post-procedure
What Are the Treatments Tested in This Trial?
Interventions
- Renal Denervation
- Splanchnic Nerve Denervation
Trial Overview
This study tests if using catheter-based radiofrequency ablation on renal arteries and splanchnic nerves can lower blood pressure and improve sugar control in patients who haven't responded well to other treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation
Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tulane University
Lead Sponsor
Citations
A Systematic Review and Network Meta‐Analysis - PMC
This study aimed to compare the blood pressure–lowering efficacy and safety of different renal denervation (RDN) techniques.
Renal Artery Denervation in Resistant Hypertension
Early studies of renal artery denervation (RAD) demonstrated efficacy in treating resistant hypertension patients with significant reduction in office blood ...
3.
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 6.5 mmHg (95% ...
Safety and Efficacy of Renal Denervation for the Treatment ...
Studies in animals with CKD have shown that renal denervation is a safe procedure that is beneficial for decreasing blood pressure and improving renal function ...
Effectiveness of renal denervation in the treatment of ...
In this group, there was a 12.2 mmHg reduction in daytime ambulatory SBP 6 months post-denervation. However, participants and physicians were ...
Targeting renal nerves for arterial hypertension – The path ...
Renal denervation has consistently shown to reduce blood pressure in patients with resistant hypertension and complex to manage blood pressure.
7.
journals.lww.com
journals.lww.com/cardiologyinreview/fulltext/9900/renal_denervation__a_new_therapy_for_resistant.423.aspxRenal Denervation: A New Therapy for Resistant ...
Renal denervation (RDN) is approved to treat resistant hypertension. RDN targets the superficial sympathetic nerves that surround the renal arteries.
Should my patients with hypertension be referred for renal ...
Recent studies have demonstrated the efficacy and safety of catheter-based renal artery denervation with radiofrequency or ultrasound energy in ...
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