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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05703620




Registration number
NCT05703620
Ethics application status
Date submitted
19/01/2023
Date registered
30/01/2023
Date last updated
30/01/2023

Titles & IDs
Public title
REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.
Scientific title
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
Secondary ID [1] 0 0
DHC20190025
Universal Trial Number (UTN)
Trial acronym
RESURRECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Diseases 0 0
Heart Failure 0 0
End Stage Renal Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Renal Denervation

Experimental: Chronic Kidney Disease - Renal Denervation

Experimental: Heart Failure - Renal Denervation

Experimental: End stage renal disease - Renal Denervation


Treatment: Devices: Renal Denervation
All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in renal sympathetic nerve activity
Timepoint [1] 0 0
BASELINE TO 3 MONTHS
Primary outcome [2] 0 0
Reduction in renal sympathetic nerve activity
Timepoint [2] 0 0
BASELINE TO 12 MONTHS
Secondary outcome [1] 0 0
Blood Pressure
Timepoint [1] 0 0
Baseline to 36 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/05/2026
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Perth Hospital
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
ReCor Medical, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT05703620
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus Schlaich
Address 0 0
Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anu Joyson
Address 0 0
Country 0 0
Phone 0 0
92240390
Fax 0 0
Email 0 0
anu.joyson@uwa.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05703620