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REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.

RECRUITING

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).

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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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

Trial ID

NCT05703620

Intervention or treatment

DEVICE: Renal Denervation

Conditions

• Chronic Kidney Diseases
• Heart Failure
• End Stage Renal Disease

Image related to Chronic Kidney Diseases

Condition: Chronic Kidney Diseases, Heart Failure and more
DEVICE: Renal Denervation
Perth, Western Australia, Australia
Sponsor: Royal Perth Hospital

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Find a site

Closest Location:

Royal Perth Hospital

Research sites nearby

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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 Renal Denervation	DEVICE: Renal Denervation All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels
EXPERIMENTAL: Heart Failure Renal Denervation	DEVICE: Renal Denervation All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels
EXPERIMENTAL: End stage renal disease Renal Denervation	DEVICE: Renal Denervation All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels

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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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.