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

RECRUITING

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).

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2021-10-08

    Primary completion: 2025-05-18

    Study completion finish: 2026-05-18

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05703620

    Intervention or treatment

    DEVICE: Renal Denervation

    Conditions

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

    Find a site

    Closest Location:

    Royal Perth Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal Perth Hospital

      Perth, Western Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/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

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Reduction in renal sympathetic nerve activitySpillover resultsBASELINE TO 3 MONTHS
    Reduction in renal sympathetic nerve activityMuscle Sympathetic Nerve Activity (MSNA)BASELINE TO 12 MONTHS

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Blood PressureChanges in systolic and diastolic blood pressuresBaseline to 36 months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.

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