Reducing sympathetic activity in patients with chronic kidney disease and heart failure using ultrasound.
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
NA · Royal Perth Hospital · NCT05703620
This study is testing if a new ultrasound treatment that targets kidney nerves can help people with chronic kidney disease and heart failure feel better and improve their heart health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Royal Perth Hospital (other) |
| Locations | 1 site (Perth, Western Australia) |
| Trial ID | NCT05703620 on ClinicalTrials.gov |
What this trial studies
This pilot trial evaluates the effects of renal denervation using the Paradise denervation system in patients with chronic kidney disease (CKD), end-stage renal disease (ESRD), and heart failure (HF). The study aims to assess the physiological response to this catheter-based ultrasound technique, which selectively targets renal nerves to potentially improve cardiovascular outcomes. By focusing on high-risk populations, the trial seeks to gather initial data that could support further randomized controlled trials in the future.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18-75 with CKD stage 3a/b, ESRD on stable renal replacement therapy, or mild to moderate heart failure with reduced ejection fraction.
Not a fit: Patients with ineligible anatomy or those who have had prior treatments for hypertension with specific devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce cardiovascular morbidity and mortality in patients with CKD, ESRD, and heart failure.
How similar studies have performed: While this approach is novel, there is evidence suggesting that targeting renal sympathetic nerve activity could improve cardiovascular outcomes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Perth, Western Australia
- Royal Perth Hospital — Perth, Western Australia, Australia (RECRUITING)
Study contacts
- Principal investigator: Markus Schlaich — Royal Perth Hospital
- Study coordinator: Anu Joyson
- Email: anu.joyson@uwa.edu.au
- Phone: 92240390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Diseases, Heart Failure, End Stage Renal Disease, Renal Denervation, Sympathetic Nervous System