Renal and Splanchnic Nerve Denervation for High Blood Pressure

Overseen By Chris Wang, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Must be taking: Oral antidiabetics, Antihypertensives

Disqualifiers: Type 1 diabetes, Aortic pathologies, others

Compensation: Varies

Number of Visits: 4

Duration: 1 day

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. ^{1 2 3 4 5}

Why 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. ^{1 3 6 7 8}

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

I have had Type 2 Diabetes for at least 5 years.

I have been on a stable dose of diabetes medication for the last 30 days.

HbA1c level ≥6.5%

Exclusion Criteria

I have had a procedure on the artery to my kidney.

I have type 1 diabetes.

My kidney function is low.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter-based endovascular denervation (CDN) of renal arteries, with or without splanchnic nerve denervation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in blood pressure and glycemic control at 1, 3, and 6 months post-procedure

6 months

3 visits (in-person)

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?

Group I: CND of Renal Arteries and Splanchnic Nerves Arm Experimental Treatment 2 Interventions

Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation

Group II: CDN of Renal arteries Arm Placebo Group 1 Intervention

Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12596002/

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.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1443950619313526

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-hypertension

Renal 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% ...

4. mdpi.com mdpi.com/2227-9059/13/8/1951

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9012033/

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 ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S156607022500075X

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.aspx

Renal 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.

8. ccjm.org ccjm.org/content/91/9/539

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 ...