Renal and Splanchnic Sympathetic Denervation as an Alternative Therapy for Resistant Hypertension and Type 2 Diabetes (RESPLASH Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in office systolic and diastolic blood pressure
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-
- •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.
排除标准
- •Estimated glomerular filtration rate of less than 30 mL/min per 1.73m
- •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.
研究组 & 干预措施
CDN of Renal arteries Arm
Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation
干预措施: Renal Denervation Only (Device)
CND of Renal Arteries and Splanchnic Nerves Arm
Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation
干预措施: Splanchnic Nerve Denervation (Device)
CND of Renal Arteries and Splanchnic Nerves Arm
Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation
干预措施: Renal Denervation Only (Device)
结局指标
主要结局
Change in office systolic and diastolic blood pressure
时间窗: 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.
次要结局
- Change in HbA1C(Baseline, 3 months)