The RESPLASH Study

Official title

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

Overview

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).

Interventions

• Device Splanchnic Nerve Denervation
  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

Primary outcome measures

• Change in office systolic and diastolic blood pressure [Time frame: Baseline, 3 months]

Secondary outcome measures (1)

• Change in HbA1C [Time frame: Baseline, 3 months]

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%
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• East Jefferson General Hospital — New Orleans

Identifiers

NCT: NCT06880562 · 2024-1510

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗