NCT04719637已完成不适用
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
Otsuka Medical Devices Co., Ltd. Japan1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2021年8月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- MIBG-cardiac(washout rate)
研究概览
简要总结
The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 II-III
- •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 m^2 (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-assist 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 / sub investigator 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
研究组 & 干预措施
PRDS-001
Experimental
Renal denervation
干预措施: PRDS-001 Renal Denervation Ultrasound System (Device)
结局指标
主要结局
MIBG-cardiac(washout rate)
时间窗: 6 months
次要结局
- Urinary noradrenalin concentration(6 months)
- Peak oxygen uptake (peak VO2) assessed by CPX(6 months)
- Ramp duration assessed by CPX(6 months)
- Peak load assessed by CPX(6 months)
- MIBG-renal (washout rate)(6 months)
- Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX(6 months)
- VE-VCO2 slope assessed by CPX(6 months)
- MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M)(6 months)
- Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing)(6 months)
- Peak VO2/heart rate assessed by CPX(6 months)
- Peak respiratory exchange ratio assessed by CPX(6 months)
- NYHA class(6 months)
- MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M)(6 months)
研究者
研究点 (1)
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