NCT04719637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

August 24, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2022

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2024

Completed
Last Updated

March 17, 2026

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

December 16, 2020

Last Update Submit

March 13, 2026

Conditions

Chronic Heart Failure

Keywords

DenervationRenal denervationHeart failureUltrasoundCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • MIBG-cardiac(washout rate)

    6 months

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (1)

PRDS-001

EXPERIMENTAL

Renal denervation

Device: PRDS-001 Renal Denervation Ultrasound System

Interventions

PRDS-001 Renal Denervation Ultrasound SystemDEVICE

Renal Denervation Ultrasound System

Also known as: renal denervation
PRDS-001

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka University Hospital

Osaka, Japan

Location

MeSH Terms

Conditions

Heart FailureCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

January 22, 2021

Study Start

August 24, 2021

Primary Completion

February 16, 2022

Study Completion

August 7, 2024

Last Updated

March 17, 2026

Record last verified: 2024-11

Locations

JP(1)