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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: PRDS-001 Renal Denervation Ultrasound System

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Osaka University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRDS-001; Renal denervation	Device: PRDS-001 Renal Denervation Ultrasound System; Renal Denervation Ultrasound System; Other Names: renal denervation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MIBG-cardiac(washout rate)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M)	6 months
Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing)	6 months
Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX	6 months
Peak oxygen uptake (peak VO2) assessed by CPX	6 months
Peak VO2/heart rate assessed by CPX	6 months
VE-VCO2 slope assessed by CPX	6 months
Peak respiratory exchange ratio assessed by CPX	6 months
Peak load assessed by CPX	6 months
Ramp duration assessed by CPX	6 months
Urinary noradrenalin concentration	6 months
NYHA class	6 months
MIBG-renal (washout rate)	6 months
MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M)	6 months

Collaborators and Investigators

• Sponsor: Otsuka Medical Devices Co., Ltd. Japan

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Actual): February 16, 2022
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Cardiovascular Diseases; Heart failure; Denervation; Renal denervation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RDN-19-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No