jRCT2052200106已完成不适用
Clinical Study of an Ultrasound Renal Denervation System in Patients with Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- -
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 85age old not（—）
- 性别
- All
入选标准
- •Patients aged 18 years or older and younger than 85 years at the time of informed consent
- •NYHA (New York Heart Association) class 2-3
- •More than 6 weeks have passed since onset of acute heart failure or acute exacerbation of chronic heart failure
- •Washout rate of MIBG [3 (meta)-iodobenzylguanidine] scintigraphy-cardiac is more than 35%
- •Patients having continued treatment of heart failure with the same dosage and administration for 4 weeks before obtaining informed consent
排除标准
- •Patients with type1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (HbA1c: >= 8%)
- •Patients whose eGFR (estimated glomerular filtration rate) is less than 40 mL/min/1.73 m2 (estimation formula by Japanese Society of Nephrology)
- •Patients with concomitant or previous autoimmune or inflammatory bowel disease
- •Patients with a history of serious lung disease
- •Patients with a history of heart transplantation or VAD [ventricle-asist device]
- •Patients receiving reserpine, tricyclic antidepressants, and labetalol hydrochloride (can be used for up to 5 half-lives before informed consent is obtained)
- •Patients being treated for Parkinson's disease or Lewy body dementia
- •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
- •Patients with persistent atrial fibrillation
- •Patients using active implantable medical devices
- •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
- •Patients with contraindications, unacceptable anaphylactic reactions, or uncontrollable allergies to contrast media
- •Female patients who are pregnant or breastfeeding
- •Patients whose office blood pressure (systolic) is 100mmHg or lower at the time of screening test
结局指标
主要结局
-
MIBG-cardiac(washout rate)
次要结局
- MIBG-cardiac(early;: heart-to-mediastinum ratio (H/M), late: H/M)
- CPX(Cardiopulmonary Exercise Training)
- Urinary noradrenalin concentration
- NYHA class
- MIBG-renal(washout rate, early: kidney-to-mediastinum ratio (K/M),late: K/M)
研究者
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