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REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-10-08
Primary completion: 2025-05-18
Study completion finish: 2026-05-18
Study type
TREATMENT
Phase
NA
Trial ID
NCT05703620
Intervention or treatment
DEVICE: Renal Denervation
Conditions
- • Chronic Kidney Diseases
- • Heart Failure
- • End Stage Renal Disease
Find a site
Closest Location:
Royal Perth Hospital
Research sites nearby
Select from list below to view details:
Royal Perth Hospital
Perth, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Chronic Kidney Disease
| DEVICE: Renal Denervation
|
EXPERIMENTAL: Heart Failure
| DEVICE: Renal Denervation
|
EXPERIMENTAL: End stage renal disease
| DEVICE: Renal Denervation
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Reduction in renal sympathetic nerve activity | Spillover results | BASELINE TO 3 MONTHS |
Reduction in renal sympathetic nerve activity | Muscle Sympathetic Nerve Activity (MSNA) | BASELINE TO 12 MONTHS |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Blood Pressure | Changes in systolic and diastolic blood pressures | Baseline to 36 months |
Frequently Asked Questions
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