RDN: Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Renal Denervation
|
Procedure: Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.
|
Outcome Measures
Primary Outcome Measures
- Cardiac Function (evaluated by MRI) [Baseline and 6 Months]
MRI Indices of Cardiac Function Myocardial mass and myocardial fibrosis Atrial and ventricular ejection function Myocardial perfusion Arterial distensibility
Secondary Outcome Measures
- Renal Function (evaluated by MRI) [Baseline, 6 Months and 24 Months]
MRI Indices of Renal Function: Renal blood flow Renal perfusion Urinary protein
- Cardiac Function [Baseline and 24 Months]
MRI Indices of Cardiac Function Myocardial mass and myocardial fibrosis Atrial and ventricular ejection function Myocardial perfusion Arterial distensibility
Eligibility Criteria
Criteria
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
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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:
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Standard CMR exclusions;
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implanted cardiac device
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intracranial metallic implants
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claustrophobia -Gadolinium-specific: estimated GFR <60 mls/min (usual clinical cut-off is <30 mls/min).
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Adenosine-specific:
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asthma / reactive airways disease
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first degree atrioventricular block
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concomitant use of dipyridamole or theophylline consumption of caffeine within 48 hours of proposed investigation
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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
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Subject has haemodynamically significant valvular heart disease
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Adelaide Hospital Adelaide | Adelaide | South Australia | Australia | 5000 |
Sponsors and Collaborators
- University of Adelaide
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CI-12-044-AU-HT