Renal Denervation for Uncontrolled Hypertension

NCT ID: NCT02016573

Last Updated: 2018-11-06

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-04-30

Brief Summary

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This is a study investigating the safety and usefulness of the Renal Denervation Procedure in reducing high blood pressure in people whose blood pressure is not adequately controlled despite already being treated with 2 blood pressure lowering drugs. This study is designed to compare the effects renal denervation to a usual care group.

Detailed Description

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This is a phase 4 randomised control trial of renal denervation for the treatment of uncontrolled hypertension.

Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure.

A total of 100 participants with uncontrolled blood pressure, treated with two blood pressure lowering medications will be recruited into the study. Patients will be assigned to one of two groups. Participants in Group 1 will be assigned to undergo the renal denervation procedure. Participants in group 2 will undergo usual care, receiving additional antihypertensive medication in an attempt to reach blood pressure targets.

The duration of this study is 36 months.

Conditions

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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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Usual care

participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets

Group Type NO_INTERVENTION

No interventions assigned to this group

Renal Denervation Group

participants randomised to undergo the renal denervation procedure

Group Type EXPERIMENTAL

Renal Denervation

Intervention Type DEVICE

Renal Denervation Catheter

Interventions

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Renal Denervation

Renal Denervation Catheter

Intervention Type DEVICE

Other Intervention Names

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Symplicity Renal Denervation Catheter

Eligibility Criteria

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Inclusion Criteria

* BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
* concurrent treatment with 2 anti-hypertensive drugs

Exclusion Criteria

* renal artery anatomy ineligible for treatment
* eGFR \<15mL/min/1.73m2 (using MDRD formula)
* individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
* female participants of child bearing potential must have negative pregnancy test prior to treatment
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 IDI Heart & Diabetes Institute

Other Identifiers

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1034397

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

070/12

Identifier Type: -

Identifier Source: org_study_id

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