Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-10-31

Brief Summary

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This is a prospective, single centre clinical investigation looking at short (6 months) and long term (24 months) changes in cardiac function and renal function in patients with drug-resistant hypertension post renal sympathetic denervation.

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Detailed Description

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Conditions

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Uncontrolled Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Denervation

Group Type OTHER

Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.

Intervention Type PROCEDURE

Interventions

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Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subject must be able and willing to comply with the required follow-up schedule
* Therapeutic Goods Association approved indications for EnligHTN™ Renal Denervation System
* Subject is ≥ 18 years of age at time of consent Subject has office SBP ≥ 160 mmHg (except for subjects with Diabetes Mellitus who must demonstrate an office SBP of ≥ 150 mm Hg) within 14 days of the procedure ◦Subject is taking ≥ 3 antihypertensive medications concurrently at maximum tolerated dose (this must include one diuretic) or subject has a documented intolerance to at least 2 out of the 4 major classes of anti-hypertensives (ACE/ARB, CCB, Diuretics, Beta Blockers and is unable to take 3 antihypertensive drugs.

Exclusion Criteria

* Standard CMR exclusions;

* implanted cardiac device
* intracranial metallic implants
* claustrophobia -Gadolinium-specific: estimated GFR \<60 mls/min (usual clinical cut-off is \<30 mls/min).
* Adenosine-specific:

* asthma / reactive airways disease
* \>first degree atrioventricular block
* concomitant use of dipyridamole or theophylline consumption of caffeine within 48 hours of proposed investigation

Subject has an identified cause of secondary hypertension

* Subject has an estimated GFR \<45 mL/min per 1.73 m2 using the MDRD formula
* Subject has undergone prior renal angioplasty, indwelling renal stents, and/or aortic stent grafts
* Subject has haemodynamically significant valvular heart disease
* Subject has a life expectancy less than 12 months, as determined by the PI
* Subject is participating in another clinical study Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
* Subject has renal arteries with diameter(s) \< 4 mm in diameter

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No