Renal Denervation to Improve Outcomes in Patients With En... | NCT02021019

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

NCT02021019

Sponsor

Baker Heart and Diabetes Institute

Status

Completed

Last Update Posted

Sep 14, 2023Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

End-stage Renal Disease
Hypertension

Interventions

Renal Denervation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1052470	Other Grant/Funding Number	NHMRC

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2022Actual

Completion Date

Dec 2022Actual

First Submitted Date

Dec 16, 2013

First Submission Date that Met QC Criteria

Dec 19, 2013

First Posted Date

Dec 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2023

Last Update Posted Date

Sep 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Renal Denervation	Experimental	Renal denervation using a catheter-based Radio-frequency approach	Procedure: Renal Denervation
Usual Care	No Intervention	Usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renal Denervation	Procedure	Renal Denervation	Renal Denervation	Symplicity Renal Denervation Catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markus P Schlaich, MD	Baker Heart and Diabetes Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baker IDI Heart and Diabetes Institute		Melbourne	Victoria	3004	Australia

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D006973	Hypertension

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided