Renal Denervation for Resistant Hypertension

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-10-31

Brief Summary

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This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.

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Detailed Description

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Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.

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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Renal Denervation Group

participants randomised to undergo the renal denervation procedure

Group Type EXPERIMENTAL

Renal Denervation

Intervention Type DEVICE

Renal Denervation Catheter

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

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

* systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes
* concurrent treatment with ≥3 anti-hypertensive drugs

Exclusion Criteria

* renal artery anatomy ineligible for treatment
* eGFR \<15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)
* female participants of childbearing 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