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

Primary Purpose

Chronic Heart Failure

Status
Active
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
PRDS-001 Renal Denervation Ultrasound System
Sponsored by
Otsuka Medical Devices Co., Ltd. Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Denervation, Renal denervation, Heart failure, Ultrasound, Cardiovascular Diseases

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Osaka University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRDS-001

Arm Description

Renal denervation

Outcomes

Primary Outcome Measures

MIBG-cardiac(washout rate)

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2020
Last Updated
March 22, 2023
Sponsor
Otsuka Medical Devices Co., Ltd. Japan
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1. Study Identification

Unique Protocol Identification Number
NCT04719637
Brief Title
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
Official Title
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Medical Devices Co., Ltd. Japan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Denervation, Renal denervation, Heart failure, Ultrasound, Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRDS-001
Arm Type
Experimental
Arm Description
Renal denervation
Intervention Type
Device
Intervention Name(s)
PRDS-001 Renal Denervation Ultrasound System
Other Intervention Name(s)
renal denervation
Intervention Description
Renal Denervation Ultrasound System
Primary Outcome Measure Information:
Title
MIBG-cardiac(washout rate)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
MIBG-cardiac(early; heart-to-mediastinum ratio (H/M), late: H/M)
Time Frame
6 months
Title
Anaerobic Threshold assessed by CPX (Cardiopulmonary Exercise Testing)
Time Frame
6 months
Title
Lowest minute ventilation (VE)/carbon dioxide output (VCO2) assessed by CPX
Time Frame
6 months
Title
Peak oxygen uptake (peak VO2) assessed by CPX
Time Frame
6 months
Title
Peak VO2/heart rate assessed by CPX
Time Frame
6 months
Title
VE-VCO2 slope assessed by CPX
Time Frame
6 months
Title
Peak respiratory exchange ratio assessed by CPX
Time Frame
6 months
Title
Peak load assessed by CPX
Time Frame
6 months
Title
Ramp duration assessed by CPX
Time Frame
6 months
Title
Urinary noradrenalin concentration
Time Frame
6 months
Title
NYHA class
Time Frame
6 months
Title
MIBG-renal (washout rate)
Time Frame
6 months
Title
MIBG-renal (early: kidney-to-mediastinum ratio (K/M), late: K/M)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Osaka University Hospital
City
Osaka
Country
Japan

12. IPD Sharing Statement

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

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