Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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