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Not yet recruitingNCT06880562Updated Sep 30, 2026

The RESPLASH Study

An interventional study of Splanchnic Nerve Denervation and Renal Denervation Only in Resistant Hypertension, sponsored by Tulane University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Tulane University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

The investigators propose a multicenter, prospective, single blind, randomized controlled pilot study. Patients with treatment-resistant hypertension and diabetes mellitus type 2 will be enrolled to undergo renal artery denervation with subsequent splanchnic nerves denervation for lowering blood pressure and glycemic levels.

20 patients will be randomly selected from outpatient cardiology clinics and will be assigned (1:1) to receive an FDA approved catheter-based denervation (CDN) of the renal arteries or CDN of the renal arteries with subsequent CDN of the splanchnic nerves at the level of the celiac artery and SMA. All patients will receive non-selective renal and mesenteric artery angiography prior and post CDN. All patients will undergo office systolic and diastolic blood pressure measurements, glycemic indices (HbA1c, fasting plasma insulin, C-peptide), and other laboratory assessments (plasma norepinephrine, renin, aldosterone, angiotensin II, lipids, and liver biochemistry) at baseline and outpatient follow-up visits (months 1, 3 and 6 post procedure).

02

Conditions studied

  • Resistant Hypertension

Keywords

  • Renal Sympathetic Denervation
  • Splanchnic Sympathetic Denervation
  • Hypertension
  • Diabetes mellitus
  • Catheter-based radiofrequency ablation
  • Lowering blood pressure
  • Control of glycemic levels
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients aged 18-75.
  • History of Type 2 Diabetes Mellitus at least 5 years prior to enrollment.
  • HbA1c level ≥6.5%
  • Use of at least 1 oral antidiabetic agent and no changes in the last 30 days.
  • History of essential hypertension with systolic Blood pressure of 160 mmHg or more (≥150 mmHg in patient with Type 2 Diabetes Mellitus), despite compliance with three of more antihypertensive drugs.
  • Stable drug regimen of at least 3 antihypertensive medications with no changes for 2 weeks before enrollment.

Exclusion criteria

Exclusion Criteria:

  • Estimated glomerular filtration rate of less than 30 mL/min per 1.73m2.
  • Type 1 diabetes mellitus.
  • History of aortic pathologies such as aneurysm or dissection confirmed by immediate preprocedural angiography that would preclude the Endovascular Denervation (EDN) procedure.
  • Orthostatic hypotension.
  • Acute or severe systemic infection.
  • History of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 3 months.
  • History of previous renal artery CDN.
  • Pregnancy or planned pregnancy during the study period.
  • Unable to provide informed consent.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Placebo comparator
    CDN of Renal arteries Arm

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

    Device: Renal Denervation Only

  • Experimental
    CND of Renal Arteries and Splanchnic Nerves Arm

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

    Device: Splanchnic Nerve Denervation · Device: Renal Denervation Only

Interventions

  • DeviceSplanchnic Nerve Denervation

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

  • DeviceRenal Denervation Only

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

05

What researchers measure

Primary outcomes

  1. Change in office systolic and diastolic blood pressure

    To assess the change in office systolic and diastolic blood pressure measurements using blood pressure cuffs at baseline to 3 months after Catheter Based Denervation (CND) at 1 month and 3 month interval.

    Time frame: Baseline, 3 months

Secondary outcomes

  1. Change in HbA1C

    To assess the change in HbA1C from baseline to 3 months after procedure and monitor the effects of renal artery denervation with subsequent splanchnic nerves denervation.

    Time frame: Baseline, 3 months

06

Study locations

1 site
  • East Jefferson General Hospital
    New Orleans, Louisiana 70006, United States
    • Chris Wang, MS · Contact · hwang37@tulane.edu · 504-988-3065
    • Suzanne Bowers, RN, BSN · Contact · sbowers@tulane.edu · 504-988-2030
    • Jose Wiley, MD, MPH, FACC, FACP, FSCAI · Principal investigator
07

Registry details

Key details

Study ID
NCT06880562
Lead sponsor
Tulane University
Responsible party
Sponsor
First posted
Mar 17, 2025
Start date
Dec 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Chris Wang, MS
Contact
hwang37@tulane.edu
504-988-3065
Suzanne Bowers, RN, BSN
Contact
sbowers@tulane.edu
504-988-2030
Jose Wiley, MD, MPH, FACC, FACP, FSCAI
principal investigator · Tulane University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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