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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Renal and Splanchnic Nerve Denervation for High Blood Pressure?

Research shows that renal denervation can lower blood pressure in patients with resistant hypertension (high blood pressure that doesn't respond to medication). Additionally, studies in animal models suggest that targeting both renal and splanchnic nerves can effectively reduce high blood pressure. ^{1 2 3 4 5}

Is renal and splanchnic nerve denervation safe for humans?

Research on renal nerve denervation, which is similar to splanchnic nerve denervation, shows it is generally safe with minimal side effects, though long-term safety beyond 3 years is still being studied. ^{1 6 7 8 9}

How does renal denervation treatment for high blood pressure differ from other treatments?

Renal denervation is unique because it targets the nerves around the kidneys to lower blood pressure, unlike traditional medications that often work by affecting the heart or blood vessels directly. This treatment is particularly promising for patients with resistant hypertension, where other treatments have failed, and it involves a catheter-based procedure to disrupt nerve signals that contribute to high blood pressure. ^{4 10 11 12 13}

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.

Research Team

Jose Wiley, MD, MPH, FACC, FACP, FSCAI

Principal Investigator

Tulane University

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%

Exclusion Criteria

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

I have type 1 diabetes.

My kidney function is low.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Preprocedural features of patients under antihypertensive drugs may help identify responders to renal denervation: a hypothesis-generating study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Selective afferent renal denervation mitigates renal and splanchnic sympathetic nerve overactivity and renal function in chronic kidney disease-induced hypertension. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Renal Denervation for Resistant Hypertension. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Reversal of genetic salt-sensitive hypertension by targeted sympathetic ablation. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Renal sympathetic denervation for treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Novel Approaches for the Treatment of the Patient with Resistant Hypertension: Renal Nerve Ablation. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Review of the state of renal nerve ablation for patients with severe and resistant hypertension. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A clinician's perspective of the role of renal sympathetic nerves in hypertension. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

STUDIES ON EXPERIMENTAL HYPERTENSION : II. THE EFFECT OF RESECTION OF SPLANCHNIC NERVES ON EXPERIMENTAL RENAL HYPERTENSION. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Selective renal denervation guided by renal nerve stimulation: mapping renal nerves for unmet clinical needs. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Anatomic assessment of sympathetic peri-arterial renal nerves in man. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Role of the Sympathetic Nervous System and Its Modulation in Renal Hypertension. [2020]