Renal Denervation to Improve Outcomes in Patients With End-stage Renal
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Blood Pressure change
Study Overview
Brief Summary
Sympathetic activation is a hallmark of end-stage renal disease and adversely affects cardiovascular prognosis. Hypertension is present in the vast majority of these patients and plays a key role in the progressive deterioration of renal function and in the exceedingly high rate of cardiovascular events. Selective catheter-based renal denervation has been shown to be safe and effective in attaining improved and sustained blood pressure control in patients with resistant hypertension and normal renal function. The investigators hypothesize that catheter-based renal denervation is a safe and effective intervention to achieve sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •end stage renal disease
- •hypertension (BP≥140/90mmHg)
Exclusion Criteria
- •Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist.
- •Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.
Outcomes
Primary Outcomes
Blood Pressure change
Time Frame: 6 months
Difference in the reduction of systolic office blood pressure between the renal denervation and control group at 6 months after the procedure
Secondary Outcomes
No secondary outcomes reported