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NCT02021019 Clinical Trial

Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease

Hypertension Clinical Trial

Official title:
Renal Denervation to Improve Outcomes in Patients With End-stage Renal

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02021019
Other study ID # 527/13
Secondary ID 1052470
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date December 2022

Study information
Verified date September 2023
Source Baker Heart and Diabetes Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Renal Denervation
Renal Denervation

Locations
Country Name City State
Australia Baker IDI Heart and Diabetes Institute Melbourne Victoria

Sponsors (1)
Lead Sponsor Collaborator
Baker Heart and Diabetes Institute

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood Pressure change Difference in the reduction of systolic office blood pressure between the renal denervation and control group at 6 months after the procedure 6 months
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