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

Study Overview
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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.

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

Conditions
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Uncontrolled Hypertension

Intervention / Treatment
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* Procedure: Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.


Participation Criteria
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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 EnligHTN™ Renal Denervation System exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Renal Denervation<br> | Procedure: Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Function (evaluated by MRI) | MRI Indices of Cardiac Function Myocardial mass and myocardial fibrosis Atrial and ventricular ejection function Myocardial perfusion Arterial distensibility | Baseline and 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function (evaluated by MRI) | MRI Indices of Renal Function: Renal blood flow Renal perfusion Urinary protein | Baseline, 6 Months and 24 Months | 
| Cardiac Function | MRI Indices of Cardiac Function Myocardial mass and myocardial fibrosis Atrial and ventricular ejection function Myocardial perfusion Arterial distensibility | Baseline and 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncontrolled hypertension, Renal denervation, Renal artery