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

JRCT ID: jRCT2052200106

Registered date:25/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic heart failure
• Date of first enrollment: 24/08/2021
• Target sample size: 15
• Study type: Interventional

Intervention(s)

Renal denervation
A balloon catheter with ultrasound source (transducer) is inserted into the renal artery in order to ablate the renal sympathetic nerves surrounding the renal artery with frictional heat generated by ultrasound while protecting the arterial wall with cooling fluid inside of the balloon simultaneously.

Outcome(s)

• Primary Outcome: MIBG-cardiac(washout rate)

Secondary Outcome

1)MIBG-cardiac(early;: heart-to-mediastinum ratio (H/M), late: H/M)
2)CPX(Cardiopulmonary Exercise Training)
3)Urinary noradrenalin concentration
4)NYHA class
5)MIBG-renal(washout rate, early: kidney-to-mediastinum ratio (K/M),late: K/M)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

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

Exclude criteria

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
11)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
12)Patients with contraindications, unacceptable anaphylactic reactions, or uncontrollable allergies to contrast media
13)Female patients who are pregnant or breastfeeding
14)Patients whose office blood pressure (systolic) is 100mmHg or lower at the time of screening test

Related Information

• Primary Sponsor: Sakata Yasushi
• Secondary ID(s): NCT04719637