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RecruitingNCT05703620RESURRECTUpdated Jan 30, 2023

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

An interventional study of Renal Denervation in Chronic Kidney Diseases, Heart Failure and End Stage Renal Disease, sponsored by Royal Perth Hospital. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-30.

Sponsored by Royal Perth Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2021, registered Jan 2023).
  • Started Oct 2021; still recruiting 5 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Chronic Kidney Diseases
  • Heart Failure
  • End Stage Renal Disease

Keywords

  • Renal Denervation
  • Sympathetic Nervous System
03

In context

Kidney Diseases

3,838 studies on the registry are indexed under Kidney Diseases; 498 are open to participants now.

This study's planned enrollment of 75 is close to the median of 70 across 2,639 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Royal Perth Hospital is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Chronic Kidney Disease

    Renal Denervation

    Device: Renal Denervation

  • Experimental
    Heart Failure

    Renal Denervation

    Device: Renal Denervation

  • Experimental
    End stage renal disease

    Renal Denervation

    Device: Renal Denervation

Interventions

  • DeviceRenal Denervation

    All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels

06

What researchers measure

Primary outcomes

  1. Reduction in renal sympathetic nerve activity

    Spillover results

    Time frame: BASELINE TO 3 MONTHS

  2. Reduction in renal sympathetic nerve activity

    Muscle Sympathetic Nerve Activity (MSNA)

    Time frame: BASELINE TO 12 MONTHS

Secondary outcomes

  1. Blood Pressure

    Changes in systolic and diastolic blood pressures

    Time frame: Baseline to 36 months

07

Study locations

1 of 1 sites recruiting
  • Royal Perth Hospital
    Perth, Western Australia 6000, Australia
    • Anu Joyson · Contact · anu.joyson@uwa.edu.au · 92240390
    • Markus Schlaich, Prof · Contact · markus.schlaich@uwa.edu.au · 92240382
    • Markus Schlaich, Prof · Principal investigator
    • Sharad Shetty, Dr · Sub investigator
    • Carl Schultz, Prof · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05703620
Lead sponsor
Royal Perth Hospital
Collaborators
ReCor Medical, Inc.
Responsible party
Professor Markus Schlaich (Principal Investigator, Royal Perth Hospital) — Principal investigator
First posted
Jan 30, 2023
Start date
Oct 8, 2021
Primary completion
May 18, 2025 (estimated)
Completion
May 18, 2026 (estimated)
Last update
Jan 30, 2023

Study contacts

Anu Joyson
Contact
anu.joyson@uwa.edu.au
92240390
Markus Schlaich
Contact
markus.schlaich@uwa.edu.au
92240382
Markus Schlaich
principal investigator · Royal Perth Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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