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

Not Applicable

Recruiting

• Conditions: Chronic Kidney Diseases; Heart Failure; End Stage Renal Disease
• Interventions: Device: Renal Denervation

• Registration Number: NCT05703620
• Lead Sponsor: Royal Perth Hospital

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.

Study Timeline

• Study Start: 2021-10-08
• Status Verified: 2023-01
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Last Update Submitted: 2023-01-19
• Study First Posted: 2023-01-30
• Last Update Posted: 2023-01-30
• Primary Completion: 2025-05-18
• Study Completion: 2026-05-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heart Failure	Renal Denervation	Renal Denervation
End stage renal disease	Renal Denervation	Renal Denervation
Chronic Kidney Disease	Renal Denervation	Renal Denervation

Primary Outcome Measures

Name	Time	Method
Reduction in renal sympathetic nerve activity	BASELINE TO 12 MONTHS	Muscle Sympathetic Nerve Activity (MSNA)

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	Baseline to 36 months	Changes in systolic and diastolic blood pressures

Trial Locations

Locations (1)

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia