NCT05703620

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Royal Perth Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Renal Denervation	All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels

Timeline

• Start date: 2021-10-08
• Primary completion: 2025-05-18
• Completion: 2026-05-18
• First posted: 2023-01-30
• Last updated: 2023-01-30

Locations

1 site across 1 country: Australia