Clinical trial NCT06880562: The RESPLASH Study
Official title: Renal and Splanchnic Sympathetic Denervation as an Alternative Therapy for Resistant Hypertension and Type 2 Diabetes (RESPLASH Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Resistant Hypertension
Keywords: Renal Sympathetic Denervation
Splanchnic Sympathetic Denervation
Hypertension
Diabetes mellitus
Catheter-based radiofrequency ablation
Lowering blood pressure
Control of glycemic levels
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-75.
* History of Type 2 Diabetes Mellitus at least 5 years prior to enrollment.
* HbA1c level ≥6.5%. (is there an upper limits cutoff?)
* 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.

Primary outcomes:
measure: Change in office systolic and diastolic blood pressure
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in HbA1C
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: East Jefferson General Hospital
state: Louisiana
Study officials:
affiliation: Tulane University
name: Jose Wiley, MD, MPH, FACC, FACP, FSCAI
role: PRINCIPAL_INVESTIGATOR
References: