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REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions. (RESURRECT)

Primary Purpose

Chronic Kidney Diseases, Heart Failure, End Stage Renal Disease

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Renal Denervation
Sponsored by
Royal Perth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Renal Denervation, Sympathetic Nervous System

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both Male and female patients Ages between 18-75 years of age Individual is competent and willing to provide written, informed consent to participate in this clinical study with either CKD stage 3a/b or ESRD on stable renal replacement therapy or Mild to moderate heart failure with reduced ejection fraction Exclusion Criteria: Ineligible anatomy Prior treatment with other devices for hypertension including but not limited to ROX Coupler (ROX Medical) , Mobius stent, and/or the CVRx (CVRx Inc) barostimulator device. Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit. Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis. Individual has clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve Individual has been admitted for inpatient hospitalization for decompensated HF in the previous month Female participants of childbearing potential must have a negative pregnancy test prior to treatment. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements. Individual is currently enrolled in another investigational drug or device trial. Note: For the purpose of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial. Individual has a disease or condition (aside from CKD, ESRD, and HFrEF) that may limit their life expectancy to < 1 year.

Sites / Locations

  • Royal Perth HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Chronic Kidney Disease

Heart Failure

End stage renal disease

Arm Description

Renal Denervation

Renal Denervation

Renal Denervation

Outcomes

Primary Outcome Measures

Reduction in renal sympathetic nerve activity
Spillover results
Reduction in renal sympathetic nerve activity
Muscle Sympathetic Nerve Activity (MSNA)

Secondary Outcome Measures

Blood Pressure
Changes in systolic and diastolic blood pressures

Full Information

First Posted
January 19, 2023
Last Updated
January 19, 2023
Sponsor
Royal Perth Hospital
Collaborators
ReCor Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05703620
Brief Title
REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.
Acronym
RESURRECT
Official Title
REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions - the RESURRECT Trial. A Pilot Proof-of-concept and Safety Study With the Paradise Denervation System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
May 18, 2025 (Anticipated)
Study Completion Date
May 18, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Perth Hospital
Collaborators
ReCor Medical, Inc.

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 is a non-randomized pilot trial, open-label evaluation of the physiologic response of native kidney denervation using the Paradise denervation system in CKD, End Stage Renal Disease (ESRD), and Heart failure (HF)
Detailed Description
There is unequivocal evidence for an important contribution of increased renal sympathetic nerve activity to cardiovascular (CV) morbidity and mortality in high risk patient cohorts with CKD, ESRD and HF. The availability of a highly effective catheter-based ultrasound device to selectively target renal nerves provides a potential unique opportunity to improve CV outcomes in these patients, a proposition that now needs to be tested in initial pilot trials and subsequent appropriately designed randomized controlled trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Heart Failure, End Stage Renal Disease
Keywords
Renal Denervation, Sympathetic Nervous System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic Kidney Disease
Arm Type
Experimental
Arm Description
Renal Denervation
Arm Title
Heart Failure
Arm Type
Experimental
Arm Description
Renal Denervation
Arm Title
End stage renal disease
Arm Type
Experimental
Arm Description
Renal Denervation
Intervention Type
Device
Intervention Name(s)
Renal Denervation
Intervention Description
All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels
Primary Outcome Measure Information:
Title
Reduction in renal sympathetic nerve activity
Description
Spillover results
Time Frame
BASELINE TO 3 MONTHS
Title
Reduction in renal sympathetic nerve activity
Description
Muscle Sympathetic Nerve Activity (MSNA)
Time Frame
BASELINE TO 12 MONTHS
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Changes in systolic and diastolic blood pressures
Time Frame
Baseline to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both Male and female patients Ages between 18-75 years of age Individual is competent and willing to provide written, informed consent to participate in this clinical study with either CKD stage 3a/b or ESRD on stable renal replacement therapy or Mild to moderate heart failure with reduced ejection fraction Exclusion Criteria: Ineligible anatomy Prior treatment with other devices for hypertension including but not limited to ROX Coupler (ROX Medical) , Mobius stent, and/or the CVRx (CVRx Inc) barostimulator device. Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit. Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis. Individual has clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve Individual has been admitted for inpatient hospitalization for decompensated HF in the previous month Female participants of childbearing potential must have a negative pregnancy test prior to treatment. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements. Individual is currently enrolled in another investigational drug or device trial. Note: For the purpose of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial. Individual has a disease or condition (aside from CKD, ESRD, and HFrEF) that may limit their life expectancy to < 1 year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anu Joyson
Phone
92240390
Email
anu.joyson@uwa.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Schlaich
Phone
92240382
Email
markus.schlaich@uwa.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Schlaich
Organizational Affiliation
Royal Perth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anu Joyson
Phone
92240390
Email
anu.joyson@uwa.edu.au
First Name & Middle Initial & Last Name & Degree
Markus Schlaich, Prof
Phone
92240382
Ext
Schlaich
Email
markus.schlaich@uwa.edu.au
First Name & Middle Initial & Last Name & Degree
Markus Schlaich, Prof
First Name & Middle Initial & Last Name & Degree
Sharad Shetty, Dr
First Name & Middle Initial & Last Name & Degree
Carl Schultz, Prof

12. IPD Sharing Statement

Learn more about this trial

REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.

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