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

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

1

Of the six cases in which consent was obtained, only one case met the eligibility criteria and underwent RDN. The patient was 83 years old and had been diagnosed with heart failure 14 years prior. There was no history of hospitalization due to heart failure.

The trial was initiated with the goal of completing the primary evaluation in 15 cases; however, the recruitment of participants was more challenging than initially anticipated. Although informed consent was obtained from six participants, none met the eligibility criteria, and the RDN procedure could not be performed in any of the cases. As a result, the trial was terminated at the stage of 1 case.

In one case where RDN was performed, three adverse events (hypertension, orthostatic hypertension, and vagal nerve reflex) occurred; however, no causal relationship was identified between these events and the investigational device PRDS-001 or the investigational procedure. No malfunctions of the investigational device PRDS-001 were observed. Renal artery stenosis exceeding 50% was not observed following the RDN procedure.Based on the above, no significant safety issues were identified during the clinical trial period in this single case.

In one case where RDN was performed, there was no significant change in the primary endpoint, MIBG-cardiac (washout rate), between before the RDN procedure and 6 months after the RDN procedure.

The trial was initiated with the goal of completing the primary evaluation in 15 cases; however, the recruitment of participants was more challenging than initially anticipated. Although informed consent was obtained from six participants, none met the eligibility criteria, and the RDN procedure could not be performed in any of the cases. As a result, the trial was terminated at the stage of 1 case.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2052200106

Sakata Yasushi

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka

OtsukaRegistry-CT@otsuka.jp

Ishinabe Kentaro

Otsuka Medical Devices Co., Ltd.

Shinagawa Grand Central Tower 13F 2-16-4, Konan, Minato-ku, Tokyo 108-0075, Japan

+81-3-6361-7459

OtsukaRegistry-CT@otsuka.jp

Complete

Dec. 25, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Chronic heart failure

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.

MIBG-cardiac(washout rate)

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)

+81-6-6210-8290

Dec. 04, 2020

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