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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04719637
• Other study ID #: RDN-19-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 24, 2021
• Est. completion date: November 2025

Study information

• Verified date: April 2024
• Source: Otsuka Medical Devices Co., Ltd. Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: November 2025
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• PRDS-001 Renal Denervation Ultrasound System
Renal Denervation Ultrasound System

Locations

Country	Name	City	State
Japan	Osaka University Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Medical Devices Co., Ltd. Japan

Country where clinical trial is conducted

Japan, 

Outcome

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