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The RESPLASH Study: Treating Resistant High Blood Pressure and Type 2 Diabetes

This study, called The RESPLASH Study, is looking at new ways to treat resistant high blood pressure (hypertension) and Type 2 Diabetes. It's testing two procedures: one uses a catheter (a thin tube) to treat the renal arteries (blood vessels in the kidneys) only, and the other treats both the renal arteries and the splanchnic nerves (nerves in your abdomen) using radiofrequency ablation (heat energy). The goal is to see if these procedures can improve your blood pressure and blood sugar levels. You might be able to join if you are 18-75 years old, have had Type 2 Diabetes for at least 5 years, have an HbA1c (a measure of blood sugar) of 6.5% or higher, and have high blood pressure that hasn't improved with at least three medications. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is a pilot study that will randomly assign 20 participants to one of two treatment groups. It is single-blind, meaning you won't know which treatment you receive.
What's involved
You will have office blood pressure measurements, blood tests for blood sugar and other markers at the start, and then at 1, 3, and 6 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the procedure to check blood pressure and other health markers.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06880562

The RESPLASH Study

Not Yet Recruiting
NAAges 18–75InterventionalTreatment
Tulane University
~20 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:Splanchnic Nerve DenervationRenal Denervation Only

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in office systolic and diastolic blood pressure
Measured over Baseline, 3 months

Conditions

Resistant Hypertension

Explore related trials

Resistant hypertensive disorderType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Louisiana1

Study leadership

  • Jose Wiley, MD, MPH, FACC, FACP, FSCAI · PRINCIPAL_INVESTIGATOR · Tulane University

Who to contact

Chris Wang, MS
[email protected]
504-988-3065
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in office systolic and diastolic blood pressureBaseline, 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.