Resistant Hypertension
Conditions
Keywords
Renal Sympathetic Denervation, Splanchnic Sympathetic Denervation, Hypertension, Diabetes mellitus, Catheter-based radiofrequency ablation, Lowering blood pressure, Control of glycemic levels
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).
Interventions
DEVICESplanchnic Nerve Denervation
Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation
DEVICERenal Denervation Only
Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation
Sponsors
Tulane University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in office systolic and diastolic blood pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1C | 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. |
Countries
United States
Contacts
CONTACTChris Wang, MS
CONTACTSuzanne Bowers, RN, BSN
PRINCIPAL_INVESTIGATORJose Wiley, MD, MPH, FACC, FACP, FSCAI
Tulane University
Outcome results
None listed