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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Chronic Kidney Diseases; End Stage Renal Disease
• Intervention / Treatment: Device: Renal Denervation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anu Joyson; Phone Number: 92240390; Email: anu.joyson@uwa.edu.au
• Study Contact Backup: Name: Markus Schlaich; Phone Number: 92240382; Email: markus.schlaich@uwa.edu.au

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Recruiting
      • Royal Perth Hospital
      • Contact: Anu Joyson; Phone Number: 92240390; Email: anu.joyson@uwa.edu.au
      • Contact: Markus Schlaich, Prof; Phone Number: Schlaich 92240382; Email: markus.schlaich@uwa.edu.au
      • Sub-Investigator: Sharad Shetty, Dr
      • Sub-Investigator: Carl Schultz, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chronic Kidney Disease; Renal Denervation	Device: Renal Denervation; All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels
Experimental: Heart Failure; Renal Denervation	Device: Renal Denervation; All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels
Experimental: End stage renal disease; Renal Denervation	Device: Renal Denervation; All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in renal sympathetic nerve activity	Spillover results	BASELINE TO 3 MONTHS
Reduction in renal sympathetic nerve activity	Muscle Sympathetic Nerve Activity (MSNA)	BASELINE TO 12 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Changes in systolic and diastolic blood pressures	Baseline to 36 months

Collaborators and Investigators

• Sponsor: Royal Perth Hospital
• Collaborators: ReCor Medical, Inc.
• Investigators: Principal Investigator: Markus Schlaich, Royal Perth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Anticipated): May 18, 2025
• Study Completion (Anticipated): May 18, 2026

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Sympathetic Nervous System; Renal Denervation
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: DHC20190025

Drug and device information, study documents

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