Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05703620
Other study ID # DHC20190025
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 8, 2021
Est. completion date May 18, 2026

Study information

Verified date January 2023
Source Royal Perth Hospital
Contact Anu Joyson
Phone 92240390
Email anu.joyson@uwa.edu.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date May 18, 2026
Est. primary completion date May 18, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Intervention

Device:
Renal Denervation
All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels

Locations

Country Name City State
Australia Royal Perth Hospital Perth Western Australia

Sponsors (2)

Lead Sponsor Collaborator
Royal Perth Hospital ReCor Medical, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in renal sympathetic nerve activity Spillover results BASELINE TO 3 MONTHS
Primary Reduction in renal sympathetic nerve activity Muscle Sympathetic Nerve Activity (MSNA) BASELINE TO 12 MONTHS
Secondary Blood Pressure Changes in systolic and diastolic blood pressures Baseline to 36 months
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy