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)
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels
Royal Perth Hospital
Perth, Western Australia, Australia
RECRUITINGReduction in renal sympathetic nerve activity
Spillover results
Time frame: BASELINE TO 3 MONTHS
Reduction in renal sympathetic nerve activity
Muscle Sympathetic Nerve Activity (MSNA)
Time frame: BASELINE TO 12 MONTHS
Blood Pressure
Changes in systolic and diastolic blood pressures
Time frame: Baseline to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.