Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure

Inclusion criteria

• 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

Exclusion criteria

• 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