CTRI/2013/09/003943进行中（未招募）3 期
Single-arm Study of Symplicityâ„¢ Renal Denervation System in Patients with Uncontrolled HyperTensioN in IndiaHTN-India
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 12
- 主要终点
- Efficacy: Change in Office Systolic Blood Pressure from baseline to 6 months post-procedure
研究概览
简要总结
The study is to evaluate efficacy and safety of renal denervation in the treatment of uncontrolled hypertension.
In this study adults with uncontrolled hypertension [systolic blood pressure ≥ 160 mmHg despite 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic] who meet inclusion/exclusion criteria will be enrolled. Subjects in the intent-to-treat population will be followed from enrollment through 6 months ±14 days for the effectiveness and safety endpoints
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individual is more than or equal to 18 and ≤ 80 years old at time of treatment.
- •2.Individual is receiving a stable medication regimen including 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic that is expected to be maintained without changes for at least 6 months.
- •3.Individual has an office systolic blood pressure (SBP) of greater than or equal to 160 mmHg based on an average of 3 blood pressure readings measured at screening visits 4.Individual or legally authorized representative 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
- •1.Individual has renal artery anatomy that is ineligible for treatment including: a.Main renal arteries with 4 mm diameter or with 20 mm treatable length (i.e., free of visible anatomic abnormality or atheroma).
- •b.Multiple renal arteries where the main renal artery is estimated to supply 75% of the kidney.
- •c.Renal artery stenosis (50%) or renal artery aneurysm in either renal artery.
- •d.A history of prior renal artery intervention including balloon angioplasty or stenting.
- •2.Individual has an estimated glomerular filtration rate (eGFR) of 45mL/min/1.73m2, using the MDRD calculation.
- •3.Individual has had 1 in-patient hospitalization for a hypertensive crisis within the past year.
- •4.Individual has type 1 diabetes mellitus.
- •5.Individual has had ≥ 1 episode(s) of orthostatic hypotension (reduction of SBP of ≥20 mmHg or DBP of ≥10 mmHg within 3 minutes of standing) coupled with symptoms within the past year or during the screening process.
- •6.Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- •7.Individual has primary pulmonary hypertension.
- •8.Individual has known secondary causes of hypertension, such as untreated pheochromocytoma, Cushing’s Disease, coarctation of the aorta, hyperthyroidism, or hyperparathyroidism.
- •9.Individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- •10.Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- •11.Individual has a condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic blood pressure monitor (e.g., arm diameter too large for the cuff, arrhythmia that interferes with automatic monitor’s pulse sensing and prohibits an accurate measurement).
- •12.Individual has severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
- •13.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 (e.g., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia).
- •14.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 angiography.] 15.Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- •16.Individual is currently enrolled in another investigational drug or device trial.
- •For the purposes of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
结局指标
主要结局
Efficacy: Change in Office Systolic Blood Pressure from baseline to 6 months post-procedure
时间窗: 6 months post-procedure
次要结局
- Safety: Incidence of Major Adverse Events (MAE), BP reduction, Chronic Safety –at 6 months post-denervation(6 months post-procedure)
研究者
研究点 (12)
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