JPRN-jRCT2052200106进行中（未招募）未知
Clinical Study of an Ultrasound Renal Denervation System in Patients with Heart Failure
Sakata Yasushi0 个研究点目标入组 15 人开始时间: 2020年12月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 85age old（—）
- 性别
- All
入选标准
- •1)Patients aged 18 years or older and younger than 85 years at the time of informed consent
- •2)NYHA (New York Heart Association) class 2-3
- •3)More than 6 weeks have passed since onset of acute heart failure or acute exacerbation of chronic heart failure
- •4)Washout rate of MIBG [3 (meta)-iodobenzylguanidine] scintigraphy-cardiac is more than 35%
- •5)Patients having continued treatment of heart failure with the same dosage and administration for 4 weeks before obtaining informed consent
排除标准
- •1)Patients with type1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (HbA1c: >= 8%)
- •2)Patients whose eGFR (estimated glomerular filtration rate) is less than 40 mL/min/1.73 m2 (estimation formula by Japanese Society of Nephrology)
- •3)Patients with concomitant or previous autoimmune or inflammatory bowel disease
- •4)Patients with a history of serious lung disease
- •5)Patients with a history of heart transplantation or VAD [ventricle-asist device]
- •6)Patients receiving reserpine, tricyclic antidepressants, and labetalol hydrochloride (can be used for up to 5 half-lives before informed consent is obtained)
- •7)Patients being treated for Parkinson's disease or Lewy body dementia
- •8)Patients with a history of any severe cardiovascular event (myocardial infarction, coronary artery bypass graft surgery, acute heart failure requiring hospitalization) or severe cerebrovascular event (stroke, transient ischemic event, cerebrovascular accident, etc.) within 3 months before obtaining informed consent
- •9)Patients with persistent atrial fibrillation
- •10)Patients using active implantable medical devices
- •11)Patients with coronary or carotid artery diseases who were deemed necessary by the principal investigator/subinvestigator to undergo surgery or PCI (Percutaneous Coronary Intervention) within 6 months after obtaining informed consent
- •12)Patients with contraindications, unacceptable anaphylactic reactions, or uncontrollable allergies to contrast media
- •13)Female patients who are pregnant or breastfeeding
- •14)Patients whose office blood pressure (systolic) is 100mmHg or lower at the time of screening test
研究者
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