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

NCT ID: NCT02021019

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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End-stage Renal Disease Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Denervation

Renal denervation using a catheter-based Radio-frequency approach

Group Type EXPERIMENTAL

Renal Denervation

Intervention Type PROCEDURE

Renal Denervation

Usual Care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Renal Denervation

Renal Denervation

Intervention Type PROCEDURE

Other Intervention Names

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Symplicity Renal Denervation Catheter

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baker Heart and Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Markus P Schlaich, MD

Role: PRINCIPAL_INVESTIGATOR

Baker Heart and Diabetes Institute

Locations

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Baker IDI Heart and Diabetes Institute

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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1052470

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

527/13

Identifier Type: -

Identifier Source: org_study_id

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