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2020年12月25日

概览

暂无简介。

注册库

who.int

开始日期

2020年12月25日

结束日期

待定

最后更新

2年前

研究类型

Interventional

性别

All

发起方

Sakata Yasushi

•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

•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