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
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.
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).
Exclusion Criteria:
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 and splanchnic nerves (celiac + SMA) using radiofrequency ablation
Device: Splanchnic Nerve Denervation · Device: Renal Denervation Only
Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation
Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation
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
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
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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Tulane University