Renal and Splanchnic Nerve Denervation for High Blood Pressure

Recruiting in Palo Alto (17 mi)

Overseen byJose Wiley, MD, MPH, FACC, FACP, FSCAI

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Tulane University

Trial Summary

What is the purpose of this trial?To assess the safety and effectiveness of renal artery denervation with subsequent splanchnic nerves denervation via catheter-based radiofrequency ablation in improving blood pressure and glycemic control in patients with resistant hypertension and type 2 diabetes.

Eligibility Criteria

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%

+3 more

Exclusion Criteria

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

I have type 1 diabetes.

My kidney function is low.

+6 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CND of Renal Arteries and Splanchnic Nerves ArmExperimental Treatment2 Interventions

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

Group II: CDN of Renal arteries ArmPlacebo Group1 Intervention

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