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2021年8月24日

适应症Chronic Heart Failure

干预措施PRDS-001 Renal Denervation Ultrasound System

概览

阶段: 不适用
干预措施: PRDS-001 Renal Denervation Ultrasound System
疾病 / 适应症: Chronic Heart Failure
发起方: Otsuka Medical Devices Co., Ltd. Japan
入组人数: 6
试验地点: 1
主要终点: MIBG-cardiac(washout rate)
状态: 已完成
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2021年8月24日

结束日期

2024年8月7日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Otsuka Medical Devices Co., Ltd. Japan

责任方

Sponsor

入排标准

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

研究组 & 干预措施

PRDS-001

Renal denervation

干预措施: PRDS-001 Renal Denervation Ultrasound System

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)