NCT01747382No Longer Available不适用
Catheter-based Renal Sympathetic Nerve Ablation for Treatment-resistant Hypertension in Patients With Chronic Kidney Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 2
研究概览
简要总结
Recent clinical studies have demonstrated that catheter-based renal sympathetic nerve ablation is safe and effective in treating patients with resistant hypertension. However, there is limited data on its safety and efficacy in patients with Chronic Kidney Disease.
The investigators hypothesize that catheter-based renal sympathetic nerve ablation is safe and effective in the treatment of resistant hypertension in patients with Chronic Kidney Disease.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual has a systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics).
- •Individual is adhering to a stable drug regimen including 3 or more anti-hypertensive medications, of which one is a diuretic, (with no changes for a minimum of 2 weeks prior to enrollment) and is expected to be maintained for at least 6 months.
- •Individual with stage 3 chronic kidney disease, defined as having an eGFR of 30 - 60 mL/min/1.73m2, using the MDRD calculation.
- •Individual is ≥ 21 and ≤ 65 years of age.
- •Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study
排除标准
- •Individual has renal artery anatomy that is ineligible for treatment including:
- •Main renal arteries < 4 mm in diameter or < 20 mm in length.
- •Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets local standards for surgical repair or interventional dilation.
- •A history of prior renal artery intervention including balloon angioplasty or stenting.
- •Multiple main renal arteries in either kidney.
- •Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation.
- •Individual has type 1 diabetes mellitus.
- •Individual has experienced a myocardial infarction, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- •Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- •Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- •Individual has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI).
- •Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
- •Individual is pregnant, nursing or planning to be pregnant. [Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.]
- •Individual is currently enrolled in another investigational drug or device trial.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Renal Sympathetic Denervation From The Adventitia on HypertensionPrimary Aldosteronism Due to Aldosterone Producing AdenomaNCT02642445Henan Institute of Cardiovascular Epidemiology60
已完成
不适用
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension PatientsHypertensionNCT01438229Abbott Medical Devices47
已完成
不适用
Full Length Versus Proximal Renal Arteries AblationHypertension, Resistant to Conventional TherapyNCT01848275The Second Affiliated Hospital of Chongqing Medical University47
已完成
不适用
REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD RecipientsVentricular TachycardiaNCT01747837Vivek Reddy48
Unknown
早期 1 期
Feasibility Study of Renal Denervation for the Treatment of Resistant HypertensionUncontrolled HypertensionNCT01865591Sound Interventions, Inc.30