The RESPLASH Study

February 27, 2026 updated by: Tulane University

Renal and Splanchnic Sympathetic Denervation as an Alternative Therapy for Resistant Hypertension and Type 2 Diabetes (RESPLASH Study)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70006
        • East Jefferson General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Wiley, MD, MPH, FACC, FACP, FSCAI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: CDN of Renal arteries Arm
Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation
Device: Renal Denervation Only
Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation
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: Renal Denervation Only
Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation
Device: Splanchnic Nerve Denervation
Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in office systolic and diastolic blood pressure
Time Frame: Baseline, 3 months
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.
Baseline, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1C
Time Frame: Baseline, 3 months
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.
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University

Investigators

  • Principal Investigator: Jose Wiley, MD, MPH, FACC, FACP, FSCAI, Tulane University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1510

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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