ACTRN12619001524189招募中未知
A Prospective, Single-Arm, Multi-Center Study of the Metavention Integrated Radio Frequency Denervation System to Improve Cardiometabolic Parameters in Hypertensive Subjects in New Zealand
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 22 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1)Age greater than or equal to 22 and less than or equal to 70 years old
- •2)Waist circumference greater than or equal to 102 cm (male) and greater than or equal to 88 cm (female)
- •3)Office systolic blood pressure (SBP) greater than or equal to 140 mmHg and less than 180 mmHg on a stable dose of antihypertensive medication(s) for at least 30 days
- •4)Documented daytime systolic ambulatory blood pressure (ABP) greater than or equal to 135 and less than 175 mmHg
- •5)Documented status of stable lifestyle modifications
- •6)Willing to comply with study requirements, including follow-up visits
- •7)Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception throughout the study
排除标准
- •8)BMI of greater than 40 kg/m2
- •9)Type 1 diabetes mellitus or uncontrolled Type 2 diabetes (uncontrolled defined as HbA1c greater than 8.5 % / 69 mmol/mol)
- •10)One or more documented hyperglycemia episodes (requiring hospitalization) in the 90 days prior to Index Procedure
- •11)One or more severe hypoglycemic events (severe cognitive impairment requiring external assistance for recovery) in the 90 days prior to Index Procedure
- •12)One or more documented severe hypertensive crisis (persistent or elevated hypertension greater than 180 mmHg accompanied by clinical symptoms) in the 90 days prior to Index Procedure
- •13)A history of bariatric surgery, renal denervation, baroreflex activation therapy, or liver transplant, or these procedures are planned in the 365 days following Index Procedure
- •14)Any surgical procedure within 30 days prior to Index Procedure
- •15)History of or current symptomatic gallstones (e.g., cholecystitis, bile duct dilatation) without a cholecystectomy being performed(Note: subjects who have had a cholecystectomy are not excluded)
- •16)Previous hepatobiliary surgery/intervention that in the opinion of the investigator could preclude the ability to perform denervation of the common hepatic artery
- •17)Use of anticoagulation therapy which cannot be discontinued from 7 days before to 14 days after the Index Procedure
- •18)Any other condition(s) that would compromise the safety of the Subject or compromise study quality as judged by the Investigator
- •19)eGFR less than 45 mL/min/1.73 m2
- •20)History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy (e.g., orthostatic hypotension attributable to autonomic neuropathy, a diagnosis of gastroparesis, or a clinical history strongly suggestive of delayed gastric emptying)
- •21)Myocardial infarction, unstable angina, stroke, or transient ischemic attack within the 180 days prior to Baseline, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques
- •22)Heart failure (New York Heart Association [NYHA] Class III-IV) at time of consent
- •23)Documented history of persistent or permanent atrial tachyarrhythmia
- •24)Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- •25)Night shift workers
- •26)Chronic regular use (e.g., daily use) of NSAIDs for 6 months or greater. Aspirin therapy is allowed.
- •27)Active implantable medical device (e.g., ICD or CRT-D, neuromodulator/spinal stimulator, baroreflex stimulator)
- •28)Known primary pulmonary HTN (greater 60 mmHg pulmonary artery or right ventricular systolic pressure)
- •29)Evidence of active infection within 7 days prior to Index Procedure
- •30)Documented history of chronic active inflammatory bowel disorders such as Crohn’s disease or ulcerative colitis
- •31)Individual has known pheochromocytoma, Cushing syndrome, primary hyperaldosteronism, coarctation of the aorta, untreated hyperthyroidism, untreated hypothyroidism, or primary hyperparathyroidism. (Note: Treated hyperthyroidism and treated hypothyroidism are permissible.)
- •32)Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count <100,000/microliter, or documented coagulopathy
- •33)Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requi
研究者
相似试验
已完成
不适用
A prospective, multi-center, single-arm study of tOCP/Col for guided bone regeneratiobone defectJPRN-UMIN000018192TOYOBO CO., LTD.60
已完成
不适用
A multicenter, open-label, single-arm study of a TRPV2 inhibitor against cardiomyopathy of muscular dystrophyJPRN-UMIN000031965ational Hospital Organization Toneyama National Hospital20
进行中（未招募）
Unknown
Tranilast-MDmuscular dystrophymuscular dystrophy ,heart failure ,tranilastmuscular dystrophiesJPRN-jRCTs031180038Matsumura Tsuyoshi20
进行中（未招募）
不适用
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial SeizuresEpilepsyPartial SeizuresMedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEUCTR2014-004335-39-Outside-EU/EEACB Japan Co. Ltd.70
尚未招募
不适用
A multi-center, single arm, prospective study of the WallFlex biliary partially covered stent for the palliative treatment of malignant bile duct obstruction.Malignant biliary obstructionmalignant obstruction of the biliary tract10019815NL-OMON30737Boston Scientific Corporation18